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Long NameStaging, Vulva NCI Standard Template
DefinitionThe collection of CDEs used in the vulva staging module based on AJCC Edition 7 and FIGO standards.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3448033
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 Vulva 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 Vulva Staging QuestionsThere are business rules to indicate situations under which this element should be used on a case report form.
Clinical T StageVulvar Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Tumor T Stage34480261.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
TXVulvar Cancer pTX TNM Finding v7Vulvar cancer in which the primary tumor cannot be assessed. (from AJCC 7th Ed.)
T0Vulvar Cancer pT0 TNM Finding v7Vulvar cancer with no evidence of primary tumor. (from AJCC 7th Ed.)
TisVulvar Cancer pTis TNM Finding v7Vulvar cancer with a finding of carcinoma in situ. (from AJCC 7th Ed.)
T1aVulvar Cancer pT1a TNM Finding v7Vulvar cancer with tumor size 2 cm or less, confined to the vulva or perineum and with stromal invasion 1.0 mm or less. The depth of invasion is defined as the measurement of the tumor from the epithelial-stromal junction of the adjacent most superficial dermal papilla to the deepest point of invasion. (from AJCC 7th Ed.)
T1bVulvar Cancer pT1b TNM Finding v7Vulvar cancer with tumor size greater than 2 cm, or any size with stromal invasion more than 1.0 mm, confined to the vulva or perineum. (from AJCC 7th Ed.)
T2Vulvar Cancer pT2 TNM Finding v7Vulvar cancer with tumor of any size with extension to adjacent perineal structures (lower/distal 1/3 urethra, lower/distal 1/3 vagina, anal involvement). (from AJCC 7th Ed.)
T3Vulvar Cancer pT3 TNM Finding v7Vulvar cancer with tumor of any size with extension to any of the following: upper/proximal 2/3 urethra, upper/proximal 2/3 vagina, bladder mucosa, rectal mucosa, or fixed to pelvic bone. (from AJCC 7th Ed.)
Clinical N StageVulvar Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Regional Lymph Node N Stage34480281.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
NXVulvar Cancer pNX TNM Finding v7Vulvar cancer in which regional lymph nodes cannot be assessed. (from AJCC 7th Ed.)
N0Vulvar Cancer pN0 TNM Finding v7Vulvar cancer without regional lymph node metastasis. (from AJCC 7th Ed.)
N1Vulvar Cancer pN1 TNM Finding v7Vulvar cancer with one or two lymph node metastasis each measuring 5 mm or less, or one lymph node metastasis measuring 5 mm or greater. (from AJCC 7th Ed.)
N1aVulvar Cancer pN1a TNM Finding v7Vulvar cancer with one or two lymph node metastasis each measuring 5 mm or less. (from AJCC 7th Ed.)
N1bVulvar Cancer pN1b TNM Finding v7Vulvar cancer with one lymph node metastasis measuring 5 mm or greater. (from AJCC 7th Ed.)
N2Vulvar Cancer pN2 TNM Finding v7Vulvar cancer with three or more lymph node metastases each measuring 5 mm or less, or two or more lymph node metastases measuring 5 mm or greater, or lymph node metastasis with extracapsular spread. (from AJCC 7th Ed.)
N2aVulvar Cancer pN2a TNM Finding v7Vulvar cancer with three or more lymph node metastases each measuring 5 mm or less. (from AJCC 7th Ed.)
N2bVulvar Cancer pN2b TNM Finding v7Vulvar cancer with two or more lymph node metastases measuring 5 mm or greater. (from AJCC 7th Ed.)
N2cVulvar Cancer pN2c TNM Finding v7Vulvar cancer with lymph node metastasis with extracapsular spread. (from AJCC 7th Ed.)
N3Vulvar Cancer pN3 TNM Finding v7Vulvar cancer with fixed or ulcerated regional lymph node metastasis. (from AJCC 7th Ed.)
Clinical M StageVulvar Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Distant Metastasis M Stage34480301.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
M0Vulvar Cancer cM0 TNM Finding v7Vulvar cancer without evidence of distant metastasis. (from AJCC 7th Ed.)
M1Vulvar Cancer cM1 TNM Finding v7Vulvar cancer with distant metastasis (including pelvic lymph node metastasis). (from AJCC 7th Ed.)
Pathologic T StageVulvar Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Tumor T Stage34480271.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
TXVulvar Cancer pTX TNM Finding v7Vulvar cancer in which the primary tumor cannot be assessed. (from AJCC 7th Ed.)
T0Vulvar Cancer pT0 TNM Finding v7Vulvar cancer with no evidence of primary tumor. (from AJCC 7th Ed.)
TisVulvar Cancer pTis TNM Finding v7Vulvar cancer with a finding of carcinoma in situ. (from AJCC 7th Ed.)
T1aVulvar Cancer pT1a TNM Finding v7Vulvar cancer with tumor size 2 cm or less, confined to the vulva or perineum and with stromal invasion 1.0 mm or less. The depth of invasion is defined as the measurement of the tumor from the epithelial-stromal junction of the adjacent most superficial dermal papilla to the deepest point of invasion. (from AJCC 7th Ed.)
T1bVulvar Cancer pT1b TNM Finding v7Vulvar cancer with tumor size greater than 2 cm, or any size with stromal invasion more than 1.0 mm, confined to the vulva or perineum. (from AJCC 7th Ed.)
T2Vulvar Cancer pT2 TNM Finding v7Vulvar cancer with tumor of any size with extension to adjacent perineal structures (lower/distal 1/3 urethra, lower/distal 1/3 vagina, anal involvement). (from AJCC 7th Ed.)
T3Vulvar Cancer pT3 TNM Finding v7Vulvar cancer with tumor of any size with extension to any of the following: upper/proximal 2/3 urethra, upper/proximal 2/3 vagina, bladder mucosa, rectal mucosa, or fixed to pelvic bone. (from AJCC 7th Ed.)
Pathologic N StageVulvar Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Regional Lymph Node N Stage34480291.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
NXVulvar Cancer pNX TNM Finding v7Vulvar cancer in which regional lymph nodes cannot be assessed. (from AJCC 7th Ed.)
N0Vulvar Cancer pN0 TNM Finding v7Vulvar cancer without regional lymph node metastasis. (from AJCC 7th Ed.)
N1Vulvar Cancer pN1 TNM Finding v7Vulvar cancer with one or two lymph node metastasis each measuring 5 mm or less, or one lymph node metastasis measuring 5 mm or greater. (from AJCC 7th Ed.)
N1aVulvar Cancer pN1a TNM Finding v7Vulvar cancer with one or two lymph node metastasis each measuring 5 mm or less. (from AJCC 7th Ed.)
N1bVulvar Cancer pN1b TNM Finding v7Vulvar cancer with one lymph node metastasis measuring 5 mm or greater. (from AJCC 7th Ed.)
N2Vulvar Cancer pN2 TNM Finding v7Vulvar cancer with three or more lymph node metastases each measuring 5 mm or less, or two or more lymph node metastases measuring 5 mm or greater, or lymph node metastasis with extracapsular spread. (from AJCC 7th Ed.)
N2aVulvar Cancer pN2a TNM Finding v7Vulvar cancer with three or more lymph node metastases each measuring 5 mm or less. (from AJCC 7th Ed.)
N2bVulvar Cancer pN2b TNM Finding v7Vulvar cancer with two or more lymph node metastases measuring 5 mm or greater. (from AJCC 7th Ed.)
N2cVulvar Cancer pN2c TNM Finding v7Vulvar cancer with lymph node metastasis with extracapsular spread. (from AJCC 7th Ed.)
N3Vulvar Cancer pN3 TNM Finding v7Vulvar cancer with fixed or ulcerated regional lymph node metastasis. (from AJCC 7th Ed.)
Pathologic M StageVulvar Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Distant Metastasis M Stage34480311.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
M1Vulvar Cancer pM1 TNM Finding v7Vulvar cancer with distant metastasis (including pelvic lymph node metastasis). (from AJCC 7th Ed.)
Disease StageVulvar Cancer American Joint Committee on Cancer (AJCC) Edition 7 Group Stage34480321.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
0Stage 0 Vulvar 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 Vulvar CancerStage I includes: T1, N0, M0. T1: Invasive vulvar cancer confined to the vulva or perineum. N0: No regional lymph node metastasis. M0: No distant metastasis. (AJCC 7th ed.)
IAStage IA Vulvar CancerStage IA includes: T1a, N0, M0. T1a: Tumor confined to the vulva and perineum, 2 cm or less in greatest dimension, and with stromal invasion no greater than 1 mm. N0: No regional lymph node metastasis. M0: No distant metastasis. (AJCC 7th ed.)
IBStage IB Vulvar CancerStage IB includes: T1b, N0, M0. T1b: Vulvar cancer with tumor size greater than 2 cm, or any size with stromal invasion more than 1.0 mm, confined to the vulva or perineum. N0: No regional lymph node metastasis. M0: No distant metastasis. (AJCC 7th ed.)
IIStage II Vulvar CancerStage II includes: T2, N0, M0. T2: Vulvar cancer with tumor of any size with extension to adjacent perineal structures (lower/distal 1/3 urethra, lower/distal 1/3 vagina, anal involvement). N0: No regional lymph node metastasis. M0: No distant metastasis. (AJCC 7th ed.)
IIIAStage IIIA Vulvar CancerStage IIIA includes: (T1/T2, N1a/N1b, M0); T1: Invasive vulvar cancer confined to the vulva or perineum. T2: Vulvar cancer with tumor of any size with extension to adjacent perineal structures (lower/distal 1/3 urethra, lower/distal 1/3 vagina, anal involvement). N1a: Vulvar cancer with one or two lymph node metastasis each measuring 5 mm or less. N1b: Vulvar cancer with one lymph node metastasis measuring 5 mm or greater. M0: No distant metastasis. (AJCC 7th ed.)
IIIBStage IIIB Vulvar CancerStage IIIB includes: (T1/T2, N2a/N2b, M0). T1: Invasive vulvar cancer confined to the vulva or perineum. T2: Vulvar cancer with tumor of any size with extension to adjacent perineal structures (lower/distal 1/3 urethra, lower/distal 1/3 vagina, anal involvement). N2a: Vulvar cancer with three or more lymph node metastases each measuring 5 mm or less. N2b: Vulvar cancer with two or more lymph node metastases measuring 5 mm or greater. M0: No distant metastasis. (AJCC 7th ed.)
IIICStage IIIC Vulvar CancerStage IIIC includes: (T1/T2, N2c, M0). T1: Invasive vulvar cancer confined to the vulva or perineum. T2: Vulvar cancer with tumor of any size with extension to adjacent perineal structures (lower/distal 1/3 urethra, lower/distal 1/3 vagina, anal involvement). N2c: Vulvar cancer with lymph node metastasis with extracapsular spread. M0: No distant metastasis. (AJCC 7th ed.)
IVAStage IVA Vulvar CancerStage IVA includes: (T1/T2, N3, M0); (T3, Any N, M0). T1: Invasive vulvar cancer confined to the vulva or perineum. T2: Vulvar cancer with tumor of any size with extension to adjacent perineal structures (lower/distal 1/3 urethra, lower/distal 1/3 vagina, anal involvement). T3: Vulvar cancer with tumor of any size with extension to any of the following: upper/proximal 2/3 urethra, upper/proximal 2/3 vagina, bladder mucosa, rectal mucosa, or fixed to pelvic bone. N3: Vulvar cancer with fixed or ulcerated regional lymph node metastasis. M0: No distant metastasis. (AJCC 7th ed.)
IVBStage IVB Vulvar CancerStage IVB includes: Any T, Any N, M1. M1: distant metastasis (including pelvic lymph node 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 Vulvar Tumor Federation of Gynecology and Obstetrics (FIGO) 2009 Stage34749901.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
IAVulvar Cancer pT1a TNM Finding v7Vulvar cancer with tumor size 2 cm or less, confined to the vulva or perineum and with stromal invasion 1.0 mm or less. The depth of invasion is defined as the measurement of the tumor from the epithelial-stromal junction of the adjacent most superficial dermal papilla to the deepest point of invasion. (from AJCC 7th Ed.)
IBVulvar Cancer pT1b TNM Finding v7Vulvar cancer with tumor size greater than 2 cm, or any size with stromal invasion more than 1.0 mm, confined to the vulva or perineum. (from AJCC 7th Ed.)
IIVulvar Cancer pT2 TNM Finding v7Vulvar cancer with tumor of any size with extension to adjacent perineal structures (lower/distal 1/3 urethra, lower/distal 1/3 vagina, anal involvement). (from AJCC 7th Ed.)
IIIVulvar Cancer pT3 TNM Finding v7Vulvar cancer with tumor of any size with extension to any of the following: upper/proximal 2/3 urethra, upper/proximal 2/3 vagina, bladder mucosa, rectal mucosa, or fixed to pelvic bone. (from AJCC 7th Ed.)
IVAVulvar Cancer pTX TNM Finding v7Vulvar cancer in which the primary tumor cannot be assessed. (from AJCC 7th Ed.)
IVBVulvar Cancer pM1 TNM Finding v7Vulvar cancer with distant metastasis (including pelvic lymph node metastasis). (from AJCC 7th Ed.)
Optional Vulva 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)