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Long NameStaging, Gestational Trophoblastic Tumor NCI Standard Template
DefinitionThe collection of CDEs used in the gestational trophoblastic tumor staging module based on AJCC Edition 7 and FIGO 2009 standards.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3447654
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionQuestion InstructionsValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Mandatory Gestational Trophoblastic Tumor Staging QuestionsThese items must be included when this data is collected for reporting.
Date Current Staging Assessment CompletedCurrent Stage Complete Assessment Date627393.0DATEMM/DD/YYYY
Conditional Gestational Trophoblastic Tumor Staging QuestionsThere are business rules to indicate situations under which this element should be used on a case report form.
Clinical T StageGestational Trophoblastic Tumor American Joint Committee on Cancer (AJCC) Edition 7 Clinical Tumor T Stage34476481.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
TXGestational Trophoblastic Tumor pTX TNM Finding v7Gestational trophoblastic tumor in which the primary tumor cannot be assessed. (from AJCC 7th Ed.)
T0Gestational Trophoblastic Tumor pT0 TNM Finding v7Gestational trophoblastic tumor with no evidence of primary tumor. (from AJCC 7th Ed.)
T1Gestational Trophoblastic Tumor pT1 TNM Finding v7Gestational trophoblastic tumor confined to uterus. (from AJCC 7th Ed.)
T2Gestational Trophoblastic Tumor pT2 TNM Finding v7Gestational trophoblastic tumor extending to other genital structures (ovary, tube, vagina, broad ligaments) by metastasis or direct extension. (from AJCC 7th Ed.)
Clinical M StageGestational Trophoblastic Tumor American Joint Committee on Cancer (AJCC) Edition 7 Clinical Distant Metastasis M Stage34476511.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
M0Gestational Trophoblastic Tumor cM0 TNM Finding v7Gestational trophoblastic tumor without evidence of distant metastasis. (from AJCC 7th Ed.)
M1Gestational Trophoblastic Tumor cM1 TNM Finding v7Gestational trophoblastic tumor with distant metastasis. (from AJCC 7th Ed.)
M1aGestational Trophoblastic Tumor cM1a TNM Finding v7Gestational trophoblastic tumor with lung metastasis. (from AJCC 7th Ed.)
M1bGestational Trophoblastic Tumor cM1b TNM Finding v7Gestational trophoblastic tumor with all other distant metastasis. (from AJCC 7th Ed.)
Pathologic T StageGestational Trophoblastic Tumor American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Tumor T Stage34476501.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
TXGestational Trophoblastic Tumor pTX TNM Finding v7Gestational trophoblastic tumor in which the primary tumor cannot be assessed. (from AJCC 7th Ed.)
T0Gestational Trophoblastic Tumor pT0 TNM Finding v7Gestational trophoblastic tumor with no evidence of primary tumor. (from AJCC 7th Ed.)
T1Gestational Trophoblastic Tumor pT1 TNM Finding v7Gestational trophoblastic tumor confined to uterus. (from AJCC 7th Ed.)
T2Gestational Trophoblastic Tumor pT2 TNM Finding v7Gestational trophoblastic tumor extending to other genital structures (ovary, tube, vagina, broad ligaments) by metastasis or direct extension. (from AJCC 7th Ed.)
Pathologic M StageGestational Trophoblastic Tumor American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Distant Metastasis M Stage34476521.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
M1Gestational Trophoblastic Tumor pM1 TNM Finding v7Gestational trophoblastic tumor with distant metastasis. (from AJCC 7th Ed.)
M1aGestational Trophoblastic Tumor pM1a TNM Finding v7Gestational trophoblastic tumor with lung metastasis. (from AJCC 7th Ed.)
M1bGestational Trophoblastic Tumor pM1b TNM Finding v7Gestational trophoblastic tumor with all other distant metastasis. (from AJCC 7th Ed.)
Disease StageGestational Trophoblastic Tumor American Joint Committee on Cancer (AJCC) Edition 7 Group Stage34476531.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
IStage I Gestational Trophoblastic TumorStage I includes: (T1, M0, Risk factors: unknown); IA (T1, M0, Risk factors: low risk); IB (T1, M0, Risk factors: high risk). T1: Tumor confined to uterus. M0: No distant metastasis. (AJCC 7th ed.)
IAStage IA Gestational Trophoblastic TumorStage IA includes: T1, M0, Risk factors: low risk. T1: Tumor confined to uterus. M0: No distant metastasis. (AJCC 7th ed.)
IBStage IB Gestational Trophoblastic TumorStage IB includes: T1, M0, Risk factors: high risk. T1: Tumor confined to uterus. M0: No distant metastasis. (AJCC 7th ed.)
IIStage II Gestational Trophoblastic TumorStage II includes: (T2, M0, Risk factors: unknown); IIA (T2, M0, Risk factors: low risk); IIB (T2, M0, Risk factors: high risk). T2: Tumor extends to other genital structures (ovary, tube, vagina, broad ligaments) by metastasis or direct extension. M0: No distant metastasis. (AJCC 7th ed.)
IIAStage IIA Gestational Trophoblastic TumorStage IIA includes: T2, M0, Risk factors: low risk. T2: Tumor extends to other genital structures (ovary, tube, vagina, broad ligaments) by metastasis or direct extension. M0: No distant metastasis. (AJCC 7th ed.)
IIBStage IIB Gestational Trophoblastic TumorStage IIB includes: T2, M0, Risk factors: high risk. T2: Tumor extends to other genital structures (ovary, tube, vagina, broad ligaments) by metastasis or direct extension. M0: No distant metastasis. (AJCC 7th ed.)
IIIStage III Gestational Trophoblastic TumorStage III includes: (Any T, M1a, Risk factors: unknown); IIIA (Any T, M1a, Risk factors: low risk); IIIB (Any T, M1a, Risk factors: high risk). M1a: Lung metastasis. (AJCC 7th ed.)
IIIAStage IIIA Gestational Trophoblastic TumorStage IIIA includes: Any T, M1a, Risk factors: low risk. M1a: Lung metastasis. (AJCC 7th ed.)
IIIBStage IIIB Gestational Trophoblastic TumorStage IIIB includes: Any T, M1a, Risk factors: high risk. M1a: Lung metastasis. (AJCC 7th ed.)
IVStage IV Gestational Trophoblastic TumorStage IV includes: (Any T, M1b, Risk factors: unknown); IVA (Any T, M1b, Risk factors: low risk); IVB (Any T, M1b, Risk factors: high risk). M1b: All other distant metastasis. (AJCC 7th ed.)
IVAStage IVA Gestational Trophoblastic TumorStage IVA includes: Any T, M1b, Risk factors: low risk. M1b: All other distant metastasis. (AJCC 7th ed.)
IVBStage IVB Gestational Trophoblastic TumorStage IVB includes: Any T, M1b, Risk factors: high risk. M1b: All other distant metastasis. (AJCC 7th ed.)
Stage unknownStage UnknownA finding indicating that the extent of organ/tissue involvement by a malignant neoplasm is not reported or not assessed.
FIGO StageGynecologic Gestational Trophoblastic Tumor Federation of Gynecology and Obstetrics (FIGO) 2009 Stage34749851.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
IFIGO Stage I Gestational Trophoblastic TumorNo Value Exists
IIFIGO Stage II Gestational Trophoblastic TumorNo Value Exists
IIIFIGO Stage III Gestational Trophoblastic TumorNo Value Exists
IVFIGO Stage IV Gestational Trophoblastic TumorNo Value Exists
Optional Gestational Trophoblastic Tumor Staging 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.
Staging Time PointDisease Staging Timepoint Name28473521.0CHARACTER
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.
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.
RestagingRestagingRepeat of staging assessment
Study EnrollmentClinical Study EnrollmentResearch conducted with human subjects or on material of human origin in which an investigator directly interacts with human subjects; includes development of new technologies, mechanism of human diseases, therapy, clinical trials, epidemiology, behavior and health services research. : Enrollment; to insert, register, or enter in a list, catalog, or roll. (Merriam-Webster Online)