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Long NameDiagnosis NCI Standard Template
DefinitionThe collection of CDEs used in the Diagnosis module.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowDRAFT NEW
TypeCRF
Public ID3921052
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Mandatory Diagnosis QuestionsThese items must be included when this data is collected for reporting.
Date of Current Pathologic DiagnosisCurrent Disease Pathologic Diagnosis Date626673.0DATEMM/DD/YYYY
Diagnosis TypeClinical Trial Disease or Disorder Diagnosis Occurrence Sequence Type39148691.0CHARACTER
PrimaryPrimary DiagnosisOccurring first in time or sequence; original; of greatest rank or importance or value.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
SecondarySecondary DiagnosisDerived as a result of a primary condition; not direct or immediate; of second rank or importance or value.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
Treatment-relatedTreatment related secondary malignancy DiagnosisA disorder characterized by development of a malignancy most probably as a result of treatment for a previously existing malignancy.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
UnknownUnknownNot known, not observed, not recorded, or refused.
Primary SitePrimary Anatomic Site Malignant Neoplasm SNOMED-CT Code39149721.0CHARACTER
Conditional Diagnosis QuestionsThere are business rules to indicate situations under which these elements should be used on a case report form.
Diagnosis Time PointDisease Diagnosis Timepoint Name28169231.0CHARACTER
Initial same as CurrentInitial diagnosis same as currentInitial diagnosis same as current
At ProgressionDisease ProgressionCancer that continues to grow or spread.
At RestagingRestagingTwo or more adjacent copies of an identical pattern.: The extent of a cancer within the body, especially whether the disease has spread from the original site to other parts of the body.
Initial DiagnosisFirst DiagnosisPreceding all others in time or space or degree.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
Current DiagnosisCurrent DiagnosisOccurring in or belonging to the present time.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
Optional Diagnosis QuestionsThere is no requirement for inclusion of these elements on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, these elements should be included.
Reviewing PathologistReviewing Pathologist Name643203.0CHARACTER
MedDRA disease codeMedDRA Code20044254.0NUMBER
Assessment MethodDisease Pathologic Confirmation Method Type39149831.0CHARACTER
CytologicCytological ProcedureTechnique or procedure for manipulation of cells and analysis of cell properties and subcellular features.
HistologicHistological ProcedureTechnique or procedure used for the study of the microanatomy of tissues and their cellular structure; usually involves microscopic examination of tissue slices.
Histologic and CytologicHistologic and Cytologic ProceduresPertaining to the combined microscopic physical features of cells and their surrounding extracellular environment in tissues.: The light microscopic study of normal and abnormal cells in fine needle aspirates (FNAs), body cavity fluids, and smears.: Having been established or verified.
Tumor gradeNeoplasm Histologic Grade27858392.0CHARACTER
G1Well DifferentiatedDescribes tumor cells that generally retain the appearance of normal cells and tend to grow and spread at a slower rate than undifferentiated or poorly differentiated tumor cells.
G2Moderately DifferentiatedDefinition not available.
G3Poorly DifferentiatedDescribes tumor cells that generally have lost most of the appearance of normal cells. They tend to grow and spread.
G4UndifferentiatedA term used to describe cells or tissues that do not have specialized ("mature") structures or functions. Undifferentiated cancer cells often grow and spread quickly.
GBBorderline Histologic GradeStraddling the dividing line between two categories.: The degree of abnormality of cancer cells, a measure of differentiation, the extent to which cancer cells are similar in appearance and function to healthy cells of the same tissue type. The degree of differentiation often relates to the clinical behavior of the particular tumor. Based on the microscopic findings, tumor grade is commonly described by one of four degrees of severity. Histopathologic grade of a tumor may be used to plan treatment and estimate the future course, outcome, and overall prognosis of disease. Certain types of cancers, such as soft tissue sarcoma, primary brain tumors, lymphomas, and breast have special grading systems.
GXGrade Cannot be AssessedAn operation in which a term denies or inverts the meaning of another term or construction.: Having determined the value, significance, or extent of.: The degree of abnormality of cancer cells, a measure of differentiation, the extent to which cancer cells are similar in appearance and function to healthy cells of the same tissue type. The degree of differentiation often relates to the clinical behavior of the particular tumor. Based on the microscopic findings, tumor grade is commonly described by one of four degrees of severity. Histopathologic grade of a tumor may be used to plan treatment and estimate the future course, outcome, and overall prognosis of disease. Certain types of cancers, such as soft tissue sarcoma, primary brain tumors, lymphomas, and breast have special grading systems.
High GradeHigh GradeUsed to describe tumor samples that exhibit poorly differentiated or undifferentiated cells. They are generally expected to be fast growing and aggressive.
Low GradeLow GradeUsed to describe tumor samples that exhibit well to moderately well differentiated cells. They are generally expected to be slow growing and less aggressive.