Oncology

The SHR Oncology domain contains basic information central to diagnosis and treatment in oncology.

BreastCancerReceptorStatus [Entry]

Immunohistochemistry (IHC) assessment for estrogen receptor (ER) and progesterone receptor (PR) as well as IHC or in situ hybridization (ISH) determination of human epidermal growth factor receptor 2 (HER2) status

Based On Panel

PanelCode is TBD required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The panel code provides the identity of the type of panel.
EstrogenReceptorStatus required Estrogen receptor alpha is the predominant estrogen receptor expressed in breast tissue and is overexpressed in around 50% of breast carcinomas. ER status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options.
ProgesteroneReceptorStatus required Progesterone receptor is expressed in 65% of breast carcinomas.13 PR status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options.
HumanEpiduralGrowthFactorReceptor2Status required HER2 is a member of the human epidermal growth factor receptor family of proteins and is encoded by the ERBB2 oncogene. HER2 is overexpressed in 20-30% of breast tumors,10 and is associated with an aggressive clinical course and poor prognosis. HER2 status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options.
ServiceCategory optional A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ReportStatus required The status of the report associated with this panel.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Specimen (TBD) 0 or more Description TBD
Interpretation 0 or more A clinical interpretation of a measurement.
Comment optional A critical or explanatory note written to discuss, support, explain changes to, or dispute information.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

BreastCancerStage [Entry]

The stage of breast cancer, assessed according to the standard established by American Joint Committee on Cancer (AJCC). TNM Stage Grouping which categorizes the progression of cancer using the Roman Numeral system. See Table 140 in HL7 CDA® R2 Implementation Guide: Clinical Oncology Treatment Plan and Summary, Release 1 - US Realm 21908-9

Based On CodeableConceptObservation

Value:  CodeableConcept from TBD A set of codes drawn from different coding systems, representing the same concept.
ObservationCode is 21908-9 required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
BreastTumorCategory required The TNM tumor category based on the tumor size (greatest dimension), based on criteria from the American Joint Committee on Cancer. See Table 152 in HL7 CDA® R2 Implementation Guide: Clinical Oncology Treatment Plan and Summary, Release 1 - US Realm
BreastNodeCategory required The presence of metastases in regional lymph nodes. TNM node category for staging derived from the American Joint Committee on Cancer. See Table 147 in HL7 CDA® R2 Implementation Guide: Clinical Oncology Treatment Plan and Summary, Release 1 - US Realm
BreastMetastatisCategory required Part of the TNM classification system representing metastases. The system is used to describe the spread of cancer to other parts of the body. See Table 144 in HL7 CDA® R2 Implementation Guide: Clinical Oncology Treatment Plan and Summary, Release 1 - US Realm
PostSurgeryIndicator optional Indicator, when true, indicates the stage is reflects the tumor size extent and location after surgical removal. If missing, it is assumed the staging is not post-surgical.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

BreastMetastatisCategory

Part of the TNM classification system representing metastases. The system is used to describe the spread of cancer to other parts of the body. See Table 144 in HL7 CDA® R2 Implementation Guide: Clinical Oncology Treatment Plan and Summary, Release 1 - US Realm 59522-3

Based On CodeableConceptObservation

Value:  CodeableConcept from TBD A set of codes drawn from different coding systems, representing the same concept.
ObservationCode is 59522-3 required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

BreastNodeCategory [Entry]

The presence of metastases in regional lymph nodes. TNM node category for staging derived from the American Joint Committee on Cancer. See Table 147 in HL7 CDA® R2 Implementation Guide: Clinical Oncology Treatment Plan and Summary, Release 1 - US Realm 59525-6

Based On CodeableConceptObservation

Value:  CodeableConcept from TBD A set of codes drawn from different coding systems, representing the same concept.
ObservationCode is 59525-6 required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

BreastTumorCategory [Entry]

The TNM tumor category based on the tumor size (greatest dimension), based on criteria from the American Joint Committee on Cancer. See Table 152 in HL7 CDA® R2 Implementation Guide: Clinical Oncology Treatment Plan and Summary, Release 1 - US Realm 59528-0

Based On CodeableConceptObservation

Value:  CodeableConcept from TBD A set of codes drawn from different coding systems, representing the same concept.
ObservationCode is 59528-0 required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

Cellularity

The percentage of cells in a sample that are cancerous C4055283

Based On QuantitativeObservation

Value:  Quantity A quantity with units.
ObservationCode required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

EstrogenReceptorStatus [Entry]

Estrogen receptor alpha is the predominant estrogen receptor expressed in breast tissue and is overexpressed in around 50% of breast carcinomas. ER status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options.

Based On ReceptorStatusObservation

Value:  CodeableConcept from PositiveNegativeVS A set of codes drawn from different coding systems, representing the same concept.
ObservationCode is TBD required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
Receptor is 23307004 required A protein located on the cell surface, or in the cytoplasm, that binds to a specific signaling factor, such as a hormone, antigen, or neurotransmitter, causing a conformational and functional change in the receptor molecule. The ligand-bound receptor then alters its interaction with target molecules, which leads to changes in cellular physiology through modification of the activity of one or more signal transduction pathways.
ReceptorPositivityPercentage optional The percentage of cells that test (stain) positive for the presence of a receptor.
ReceptorProportionScore optional Part of Allred scoring, based on the percentage of cells that stain for a receptor, on a scale of 0 to 5.
ReceptorIntensityScore optional Part of the Allred scoring, based on the intensity of that staining, on a scale of 0 to 3.
ReceptorTotalScore optional Part of the Allred scoring, the total of proportion and intensity scores, from 0 to 8.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

HumanEpiduralGrowthFactorReceptor2Status [Entry]

HER2 is a member of the human epidermal growth factor receptor family of proteins and is encoded by the ERBB2 oncogene. HER2 is overexpressed in 20-30% of breast tumors,10 and is associated with an aggressive clinical course and poor prognosis. HER2 status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options. C3810543

Based On ReceptorStatusObservation

Value:  CodeableConcept from PositiveNegativeVS A set of codes drawn from different coding systems, representing the same concept.
ObservationCode is C3810543 required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
Receptor is TBD required A protein located on the cell surface, or in the cytoplasm, that binds to a specific signaling factor, such as a hormone, antigen, or neurotransmitter, causing a conformational and functional change in the receptor molecule. The ligand-bound receptor then alters its interaction with target molecules, which leads to changes in cellular physiology through modification of the activity of one or more signal transduction pathways.
ReceptorPositivityPercentage optional The percentage of cells that test (stain) positive for the presence of a receptor.
ReceptorProportionScore optional Part of Allred scoring, based on the percentage of cells that stain for a receptor, on a scale of 0 to 5.
ReceptorIntensityScore optional Part of the Allred scoring, based on the intensity of that staining, on a scale of 0 to 3.
ReceptorTotalScore optional Part of the Allred scoring, the total of proportion and intensity scores, from 0 to 8.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

LargestLymphNodeSize

No Description C1285847

Based On QuantitativeObservation

Value:  Quantity Units is mm A quantity with units.
ObservationCode required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

MetastaticBreastCancerDiagnosis [Entry]

A diagnosis of Stage IV breast cancer, cancer originating in the breast that has spread to other organs of the body, most often the bones, lungs, liver, or brain. C1446377

Based On Problem

Value:  CodeableConcept from MetastaticBreastCancerDiagnosisVS A set of codes drawn from different coding systems, representing the same concept.
ProblemCategory includes disease 0 or more A categorization of the problem using common clinical categories.
GradeOrStage is Clinical stage IV (2640006) required The stage or grade of a disease.
BodySite must be a PrimaryTumorBodySite required Location on or in the body.
NonOccurrenceModifier not used When true, indicates either that the event or action documented in the entry did not occur, or the the thing documented is absent or does not exist.
IncludeOnProblemList is true optional Whether or not to include this problem on the subject's current problem list.
GeneralizedLikelihood optional Quantitative or qualitative measure of likelihood.
SupportingEvidenceQuality optional An assessment of the quality and/or quantity of the source information that supports judgment.
ClinicalStatus required A flag indicating whether the problem is active or inactive, recurring, in remission, or resolved.
Onset optional The beginning or first appearance of a mental or physical disorder.
WhenClinicallyRecognized optional The time at which a condition or problem was first identified in a healthcare context.
Preexisting optional If the problem or condition existed before the current episode of care.
Abatement optional The end, remission or resolution.
Severity optional Degree of severity of a symptom, disorder, or problem.
Criticality optional A clinical judgment of potential clinical harm, or seriousness, of a condition. When the worst case result is assessed to have a life-threatening or organ system threatening potential, it is considered to be of high criticality.
Manifestation 0 or more A complaint or observed (subjective) indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

PercentageInSituCarcinoma

The percentage of the cancer that is in situ, as opposed to invading other tissues.

Based On QuantitativeObservation

Value:  Quantity A quantity with units.
ObservationCode required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

PostSurgeryIndicator

Indicator, when true, indicates the stage is reflects the tumor size extent and location after surgical removal. If missing, it is assumed the staging is not post-surgical.

Value:  boolean

PrimaryTumorBodySite

The body site of the primary tumor.

Based On BodySite

Value:  CodeableConcept from BodySiteVS A set of codes drawn from different coding systems, representing the same concept.
Laterality optional Anatomical location or specimen further detailing the side(s) of interest.
Directionality optional Anatomical location or specimen further detailing directionality.
PortionTotality optional ObservationQualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of an entity.
Description optional An account, representation, statement, or explanation of something.

ProgesteroneReceptorStatus [Entry]

Progesterone receptor is expressed in 65% of breast carcinomas.13 PR status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options.

Based On ReceptorStatusObservation

Value:  CodeableConcept from PositiveNegativeVS A set of codes drawn from different coding systems, representing the same concept.
ObservationCode is TBD required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
Receptor is 61078009 required A protein located on the cell surface, or in the cytoplasm, that binds to a specific signaling factor, such as a hormone, antigen, or neurotransmitter, causing a conformational and functional change in the receptor molecule. The ligand-bound receptor then alters its interaction with target molecules, which leads to changes in cellular physiology through modification of the activity of one or more signal transduction pathways.
ReceptorPositivityPercentage optional The percentage of cells that test (stain) positive for the presence of a receptor.
ReceptorProportionScore optional Part of Allred scoring, based on the percentage of cells that stain for a receptor, on a scale of 0 to 5.
ReceptorIntensityScore optional Part of the Allred scoring, based on the intensity of that staining, on a scale of 0 to 3.
ReceptorTotalScore optional Part of the Allred scoring, the total of proportion and intensity scores, from 0 to 8.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

Receptor

A protein located on the cell surface, or in the cytoplasm, that binds to a specific signaling factor, such as a hormone, antigen, or neurotransmitter, causing a conformational and functional change in the receptor molecule. The ligand-bound receptor then alters its interaction with target molecules, which leads to changes in cellular physiology through modification of the activity of one or more signal transduction pathways. C0597357

Value:  CodeableConcept from ReceptorVS A set of codes drawn from different coding systems, representing the same concept.

ReceptorIntensityScore

Part of the Allred scoring, based on the intensity of that staining, on a scale of 0 to 3.

Value:  unsignedInt

ReceptorPositivityPercentage

The percentage of cells that test (stain) positive for the presence of a receptor.

Value:  Percentage A percentage value where 100.0 represents 100%.

ReceptorProportionScore

Part of Allred scoring, based on the percentage of cells that stain for a receptor, on a scale of 0 to 5.

Value:  unsignedInt

ReceptorStatusObservation

Refers to the presence or absence of specific receptor molecules on the surface of a cells in a specimen. C0449443

Based On CodeableConceptObservation

Value:  CodeableConcept from PositiveNegativeVS A set of codes drawn from different coding systems, representing the same concept.
Receptor required A protein located on the cell surface, or in the cytoplasm, that binds to a specific signaling factor, such as a hormone, antigen, or neurotransmitter, causing a conformational and functional change in the receptor molecule. The ligand-bound receptor then alters its interaction with target molecules, which leads to changes in cellular physiology through modification of the activity of one or more signal transduction pathways.
ReceptorPositivityPercentage optional The percentage of cells that test (stain) positive for the presence of a receptor.
ReceptorProportionScore optional Part of Allred scoring, based on the percentage of cells that stain for a receptor, on a scale of 0 to 5.
ReceptorIntensityScore optional Part of the Allred scoring, based on the intensity of that staining, on a scale of 0 to 3.
ReceptorTotalScore optional Part of the Allred scoring, the total of proportion and intensity scores, from 0 to 8.
ObservationCode required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

ReceptorTotalScore

Part of the Allred scoring, the total of proportion and intensity scores, from 0 to 8.

Value:  unsignedInt

SizeOfGrossTumorBed [Entry]

The largest dimension of the gross tumor bed/fibrotic area. TBD

Based On QuantitativeObservation

Value:  Quantity Units is mm A quantity with units.
ObservationCode required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

TumorMargins

The edge or border of the tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed. C1269830

Based On CodeableConceptObservation

Value:  CodeableConcept from PositiveNegativeVS A set of codes drawn from different coding systems, representing the same concept.
ObservationCode required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

TumorMeasurements [Entry]

Measurements and assessment of tumor, in situ via imaging, or of removed tumor. See CDISC Table 3.3.2 C4086369

Based On Panel

PanelCode is C4086369 required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The panel code provides the identity of the type of panel.
TumorPrimaryDimensionSize required The longest diameter of the primary tumor.
TumorSecondaryDimensionSize optional The longest perpendicular diameter of the primary tumor.
SizeOfGrossTumorBed optional The largest dimension of the gross tumor bed/fibrotic area.
TumorMargins optional The edge or border of the tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.
Cellularity optional The percentage of cells in a sample that are cancerous
PercentageInSituCarcinoma optional The percentage of the cancer that is in situ, as opposed to invading other tissues.
ServiceCategory optional A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ReportStatus required The status of the report associated with this panel.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Specimen (TBD) 0 or more Description TBD
Interpretation 0 or more A clinical interpretation of a measurement.
Comment optional A critical or explanatory note written to discuss, support, explain changes to, or dispute information.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

TumorPrimaryDimensionSize [Entry]

The longest diameter of the primary tumor.

Based On QuantitativeObservation

Value:  Quantity Units is mm A quantity with units.
ObservationCode required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.

TumorSecondaryDimensionSize [Entry]

The longest perpendicular diameter of the primary tumor.

Based On QuantitativeObservation

Value:  Quantity Units is mm A quantity with units.
ObservationCode required A term from a controlled vocabulary that defines the data element (the question, not the answer) as specifically as possible. The specific code should always align with the concept of the element, but may be more specific. For example, the concept associated with medications is code for 'medication used', but the ObservationCode is the code for the particular medication used. For tests, ObservationCode identifies the specific test being performed, and for observations, the specific question being asked.
ObservationCategory 0 or more A categorization of the observation according to how the observation was collected or its clinical area.
ObservationReason optional The reason for making the observation.
ObservationNonOccurrenceModifier optional True if the observation did not occcur, e.g., if a test was not performed or the assessment was not done, when it might otherwise be expected.
ObservationStatus required A qualifier describing the stage or administrative state of the observation. If not given, it is assumed the status is final.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
ObservationMethod optional The method of the observation, for example, the specific imaging technical or assessment vehicle.
ClinicallyRelevantTime optional The time or time period that the observation addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
Participant 0 or more A statement about an actor who did (or did not) participate in a certain task or activity. Unlike a HealthcareInvolvement which continues over period of time, the participant is associated with doing or not doing a specific task, such admitting a patient, performing a procedure, or taking a measurement.
Setting 0 or more Description of the place or type of surroundings where something is positioned or where an event takes place.
Location 0 or more A position, site, or point in space where something can be found.