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Long NameStaging, Vagina NCI Standard Template
DefinitionThe collection of CDEs used in the vagina staging module based on AJCC Edition 7 and FIGO 2009 standards.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3451637
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 Vagina 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 Vagina Staging QuestionsThere are business rules to indicate situations under which this element should be used on a case report form.
Clinical T StageVaginal Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Tumor T Stage34516261.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
TXVaginal Cancer pTX TNM Finding v7Vaginal cancer in which the primary tumor cannot be assessed. (from AJCC 7th Ed.)
T0Vaginal Cancer pT0 TNM Finding v7Vaginal cancer with no evidence of primary tumor. (from AJCC 7th Ed.)
TisVaginal Cancer pTis TNM Finding v7Vaginal cancer with a finding of carcinoma in situ. (from AJCC 7th Ed.)
T1Vaginal Cancer pT1 TNM Finding v7Vaginal cancer with a tumor confined to vagina. (from AJCC 7th Ed.)
T2Vaginal Cancer pT2 TNM Finding v7Vaginal cancer invading the paravaginal tissues but not the pelvic wall. (from AJCC 7th Ed.)
T3Vaginal Cancer pT3 TNM Finding v7Vaginal cancer extending to the pelvic wall. Pelvic wall is defined as muscle, fascia, neurovascular structures, or skeletal portions of the bony pelvis. (from AJCC 7th Ed.)
T4Vaginal Cancer pT4 TNM Finding v7Vaginal cancer invading the mucosa of the bladder or rectum and/or extending beyond the true pelvis (bullous edema is not sufficient evidence to classify a tumor as T4) . (from AJCC 7th Ed.)
Clinical N StageVaginal Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Regional Lymph Node N Stage34516311.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
NXVaginal Cancer pNX TNM Finding v7Vaginal cancer in which regional lymph nodes cannot be assessed. (from AJCC 7th Ed.)
N0Vaginal Cancer pN0 TNM Finding v7Vaginal cancer without regional lymph node metastasis. (from AJCC 7th Ed.)
N1Vaginal Cancer pN1 TNM Finding v7Vaginal cancer with pelvic or inguinal lymph node metastasis. (from AJCC 7th Ed.)
Clinical M StageVaginal Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Distant Metastasis M Stage34516341.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
M0Vaginal Cancer cM0 TNM Finding v7Vaginal cancer without evidence of distant metastasis. (from AJCC 7th Ed.)
M1Vaginal Cancer cM1 TNM Finding v7Vaginal cancer with distant metastasis. (from AJCC 7th Ed.)
Pathologic T StageVaginal Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Tumor T Stage34516281.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
TXVaginal Cancer pTX TNM Finding v7Vaginal cancer in which the primary tumor cannot be assessed. (from AJCC 7th Ed.)
T0Vaginal Cancer pT0 TNM Finding v7Vaginal cancer with no evidence of primary tumor. (from AJCC 7th Ed.)
TisVaginal Cancer pTis TNM Finding v7Vaginal cancer with a finding of carcinoma in situ. (from AJCC 7th Ed.)
T1Vaginal Cancer pT1 TNM Finding v7Vaginal cancer with a tumor confined to vagina. (from AJCC 7th Ed.)
T2Vaginal Cancer pT2 TNM Finding v7Vaginal cancer invading the paravaginal tissues but not the pelvic wall. (from AJCC 7th Ed.)
T3Vaginal Cancer pT3 TNM Finding v7Vaginal cancer extending to the pelvic wall. Pelvic wall is defined as muscle, fascia, neurovascular structures, or skeletal portions of the bony pelvis. (from AJCC 7th Ed.)
T4Vaginal Cancer pT4 TNM Finding v7Vaginal cancer invading the mucosa of the bladder or rectum and/or extending beyond the true pelvis (bullous edema is not sufficient evidence to classify a tumor as T4) . (from AJCC 7th Ed.)
Pathologic N StageVaginal Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Regional Lymph Node N Stage34516331.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
NXVaginal Cancer pNX TNM Finding v7Vaginal cancer in which regional lymph nodes cannot be assessed. (from AJCC 7th Ed.)
N0Vaginal Cancer pN0 TNM Finding v7Vaginal cancer without regional lymph node metastasis. (from AJCC 7th Ed.)
N1Vaginal Cancer pN1 TNM Finding v7Vaginal cancer with pelvic or inguinal lymph node metastasis. (from AJCC 7th Ed.)
Pathologic M StageVaginal Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Distant Metastasis M Stage34516351.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
M1Vaginal Cancer pM1 TNM Finding v7Vaginal cancer with distant metastasis. (from AJCC 7th Ed.)
Disease StageVaginal Cancer American Joint Committee on Cancer (AJCC) Edition 7 Group Stage34516361.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
0Stage 0 Vaginal CancerStage 0 includes: Tis, N0, M0. Tis: Carcinoma in situ (preinvasive carcinoma). N0: No regional lymph node metastasis. M0: No distant metastasis. FIGO no longer includes stage 0. (AJCC 7th ed.)
IStage I Vaginal CancerStage I includes: (T1, N0, M0). T1: Tumor confined to vagina. N0: No regional lymph node metastasis. M0: No distant metastasis. (AJCC 6th and 7th eds.)
IIStage II Vaginal CancerStage II includes: T2, N0, M0. T2: Tumor invades paravaginal tissues but not to pelvic wall. N0: No regional lymph node metastasis. M0: No distant metastasis. (AJCC 6th and 7th eds.)
IIIStage III Vaginal CancerStage III includes: (T1-3, N1, M0) and (T3, N0, M0). T1: Tumor confined to vagina. T2: Tumor invades paravaginal tissues but not to pelvic wall. T3: Tumor extends to pelvic wall. N0: No regional lymph node metastasis. N1: Pelvic or inguinal lymph node metastasis. M0: No distant metastasis. (AJCC 6th and 7th eds.)
IVAStage IVA Vaginal CancerStage IVA includes: T4, Any N, M0. T4: Tumor invades mucosa of the bladder or rectum and/or extends beyond the true pelvis (bullous edema is not sufficient evidence to classify a tumor as T4). M0: No distant metastasis. (AJCC 6th and 7th eds.)
IVBStage IVB Vaginal CancerStage IVB includes: Any T, Any N, M1. M1: Distant metastasis. (AJCC 6th and 7th eds.)
Stage unknownStage UnknownA finding indicating that the extent of organ/tissue involvement by a malignant neoplasm is not reported or not assessed.
FIGO StageGynecologic Vaginal Tumor Federation of Gynecology and Obstetrics (FIGO) 2009 Stage34749891.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
IVaginal Cancer pT1 TNM Finding v7Vaginal cancer with a tumor confined to vagina. (from AJCC 7th Ed.)
IIVaginal Cancer pT2 TNM Finding v7Vaginal cancer invading the paravaginal tissues but not the pelvic wall. (from AJCC 7th Ed.)
IIIVaginal Cancer pT3 TNM Finding v7Vaginal cancer extending to the pelvic wall. Pelvic wall is defined as muscle, fascia, neurovascular structures, or skeletal portions of the bony pelvis. (from AJCC 7th Ed.)
IVAVaginal Cancer pT4 TNM Finding v7Vaginal cancer invading the mucosa of the bladder or rectum and/or extending beyond the true pelvis (bullous edema is not sufficient evidence to classify a tumor as T4) . (from AJCC 7th Ed.)
IVBVaginal Cancer pM1 TNM Finding v7Vaginal cancer with distant metastasis. (from AJCC 7th Ed.)
Optional Vagina 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)