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Long NameStaging, Melanoma of the Skin NCI Standard Template
DefinitionThe collection of CDEs used in the cutaneous melanoma staging module based on AJCC Edition 7.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3443473
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 Cutaneous Melanoma 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 Cutaneous Melanoma Staging QuestionsThere are business rules to indicate situations under which this element should be used on a case report form.
Clinical T StageCutaneous Melanoma American Joint Committee on Cancer (AJCC) Edition 7 Clinical Tumor T Stage33576371.0CHARACTER
TXCutaneous Melanoma pTX TNM Finding v7Cutaneous melanoma in which the primary tumor cannot be assessed (e.g., curettaged or severely regressed melanoma). (from AJCC 7th Ed.)
T0Cutaneous Melanoma pT0 TNM FindingCutaneous melanoma with no evidence of primary tumor. (from AJCC 6th and 7th Eds.)
TisCutaneous Melanoma pTis TNM FindingCutaneous melanoma in situ. (from AJCC 6th and 7th Eds.)
T1Cutaneous Melanoma pT1 TNM Finding v7Cutaneous melanoma with a tumor measuring 1.0 mm or less in thickness. (from AJCC 7th Ed.)
T1aCutaneous Melanoma pT1a TNM Finding v7Cutaneous melanoma with a tumor measuring 1.0 mm or less in thickness, without ulceration and with mitosis less than 1/mm2. (from AJCC 7th Ed.)
T1bCutaneous Melanoma pT1b TNM Finding v7Cutaneous melanoma with a tumor measuring 1.0 mm or less in thickness, with ulceration or mitoses equal to or more than 1/mm2. (from AJCC 7th Ed.)
T2Cutaneous Melanoma pT2 TNM FindingCutaneous melanoma 1.01 to 2 mm in thickness, with or without ulceration. (from AJCC 6th and 7th Eds.)
T2aCutaneous Melanoma pT2a TNM FindingCutaneous melanoma 1.01 to 2 mm in thickness, with no ulceration. (from AJCC 6th and 7th Eds.)
T2bCutaneous Melanoma pT2b TNM FindingCutaneous melanoma 1.01 to 2 mm thick, with ulceration. (from AJCC 6th and 7th Eds.)
T3Cutaneous Melanoma pT3 TNM FindingCutaneous melanoma 2.01 to 4 mm thick, with or without ulceration. (from AJCC 6th and 7th Eds.)
T3aCutaneous Melanoma pT3a TNM FindingCutaneous melanoma 2.01 to 4 mm in thickness, with no ulceration. (from AJCC 6th and 7th Eds.)
T3bCutaneous Melanoma pT3b TNM FindingCutaneous melanoma 2.01 to 4 mm thick, with ulceration. (from AJCC 6th and 7th Eds.)
T4Cutaneous Melanoma pT4 TNM FindingCutaneous melanoma greater than 4.0 mm in thickness, with or without ulceration. (from AJCC 6th and 7th Eds.)
T4aCutaneous Melanoma pT4a TNM FindingCutaneous melanoma greater than 4.0 mm in thickness, without ulceration. (from AJCC 6th and 7th Eds.)
T4bCutaneous Melanoma pT4b TNM FindingCutaneous melanoma greater than 4.0 mm in thickness, with ulceration. (from AJCC 6th and 7th Eds.)
Clinical N StageCutaneous Melanoma American Joint Committee on Cancer (AJCC) Edition 7 Clinical Regional Lymph Node N Stage33576391.0CHARACTER
N0Cutaneous Melanoma cN0 TNM Finding v7Cutaneous melanoma in which no regional metastases are detected. (from AJCC 7th Ed.)
N1Cutaneous Melanoma cN1 TNM Finding v7Cutaneous melanoma with macrometastasis in one regional lymph node. Macrometastases are defined as clinically detectable nodal metastases confirmed by therapeutic lymphadenectomy or when nodal metastasis exhibits gross extracapsular extension. (from AJCC 7th Ed.)
N2cCutaneous Melanoma cN2c TNM Finding v7Cutaneous melanoma with intralymphatic metastases (in transit or satellite metastases) without metastatic nodes. (from AJCC 7th Ed.)
N3Cutaneous Melanoma cN3 TNM Finding v7Cutaneous melanoma with 1 or more metastatic nodes with in transit met(s)/satellite(s). (from AJCC 7th Ed.)
NXCutaneous Melanoma cNX TNM Finding v7Cutaneous melanoma in which the regional lymph nodes cannot be assessed (e.g., previously removed for another reason). (from AJCC 7th Ed.)
Clinical M StageCutaneous Melanoma American Joint Committee on Cancer (AJCC) Edition 7 Clinical Distant Metastasis M Stage33576401.0CHARACTER
M0Cutaneous Melanoma cM0 TNM Finding v7Cutaneous melanoma with no detectable evidence of distant metastases. (from AJCC 7th Ed.)
M1aCutaneous Melanoma cM1a TNM Finding v7Cutaneous melanoma with metastases to skin, subcutaneous tissues, or distant lymph nodes associated with normal serum lactate dehydrogenase (LDH). (from AJCC 7th Ed.)
M1bCutaneous Melanoma cM1b TNM Finding v7Cutaneous melanoma with metastases to lung associated with normal serum lactate dehydrogenase (LDH). (from AJCC 7th Ed.)
M1cCutaneous Melanoma cM1c TNM Finding v7Cutaneous melanoma with metastases to all other visceral sites associated with normal serum lactate dehydrogenase (LDH) or distant metastases to any site associated with an elevated serum LDH. (from AJCC 7th Ed.)
Pathologic T StageCutaneous Melanoma American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Tumor T Stage33576381.0CHARACTER
TXCutaneous Melanoma pTX TNM Finding v7Cutaneous melanoma in which the primary tumor cannot be assessed (e.g., curettaged or severely regressed melanoma). (from AJCC 7th Ed.)
T0Cutaneous Melanoma pT0 TNM FindingCutaneous melanoma with no evidence of primary tumor. (from AJCC 6th and 7th Eds.)
TisCutaneous Melanoma pTis TNM FindingCutaneous melanoma in situ. (from AJCC 6th and 7th Eds.)
T1Cutaneous Melanoma pT1 TNM Finding v7Cutaneous melanoma with a tumor measuring 1.0 mm or less in thickness. (from AJCC 7th Ed.)
T1aCutaneous Melanoma pT1a TNM Finding v7Cutaneous melanoma with a tumor measuring 1.0 mm or less in thickness, without ulceration and with mitosis less than 1/mm2. (from AJCC 7th Ed.)
T1bCutaneous Melanoma pT1b TNM Finding v7Cutaneous melanoma with a tumor measuring 1.0 mm or less in thickness, with ulceration or mitoses equal to or more than 1/mm2. (from AJCC 7th Ed.)
T2Cutaneous Melanoma pT2 TNM FindingCutaneous melanoma 1.01 to 2 mm in thickness, with or without ulceration. (from AJCC 6th and 7th Eds.)
T2aCutaneous Melanoma pT2a TNM FindingCutaneous melanoma 1.01 to 2 mm in thickness, with no ulceration. (from AJCC 6th and 7th Eds.)
T2bCutaneous Melanoma pT2b TNM FindingCutaneous melanoma 1.01 to 2 mm thick, with ulceration. (from AJCC 6th and 7th Eds.)
T3Cutaneous Melanoma pT3 TNM FindingCutaneous melanoma 2.01 to 4 mm thick, with or without ulceration. (from AJCC 6th and 7th Eds.)
T3aCutaneous Melanoma pT3a TNM FindingCutaneous melanoma 2.01 to 4 mm in thickness, with no ulceration. (from AJCC 6th and 7th Eds.)
T3bCutaneous Melanoma pT3b TNM FindingCutaneous melanoma 2.01 to 4 mm thick, with ulceration. (from AJCC 6th and 7th Eds.)
T4Cutaneous Melanoma pT4 TNM FindingCutaneous melanoma greater than 4.0 mm in thickness, with or without ulceration. (from AJCC 6th and 7th Eds.)
T4aCutaneous Melanoma pT4a TNM FindingCutaneous melanoma greater than 4.0 mm in thickness, without ulceration. (from AJCC 6th and 7th Eds.)
T4bCutaneous Melanoma pT4b TNM FindingCutaneous melanoma greater than 4.0 mm in thickness, with ulceration. (from AJCC 6th and 7th Eds.)
Pathologic N StageCutaneous Melanoma American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Regional Lymph Node N Stage33576411.0CHARACTER
NXCutaneous Melanoma pNX TNM Finding v7Cutaneous melanoma in which the regional lymph nodes cannot be assessed (e.g., previously removed for another reason). (from AJCC 7th Ed.)
N0Cutaneous Melanoma pN0 TNM FindingCutaneous melanoma without involvement of regional lymph nodes. (from AJCC 6th and 7th Eds.)
N1Cutaneous Melanoma pN1 TNM Finding v7Cutaneous melanoma with metastasis in one regional lymph node. (from AJCC 7th Ed.)
N1aCutaneous Melanoma pN1a TNM Finding v7Cutaneous melanoma with micrometastasis in one regional lymph node. Micrometastases are diagnosed after sentinel lymph node biopsy and completion of lymphadenectomy (if performed). (from AJCC 7th Ed.)
N1bCutaneous Melanoma pN1b TNM Finding v7Cutaneous melanoma with macrometastasis in one regional lymph node. Macrometastases are defined as clinically detectable nodal metastases confirmed by therapeutic lymphadenectomy or when nodal metastasis exhibits gross extracapsular extension. (from AJCC 7th Ed.)
N2Cutaneous Melanoma pN2 TNM Finding v7Cutaneous melanoma with metastases in 2-3 regional lymph nodes or in transit met(s)/satellite(s) without metastatic nodes. (from AJCC 7th Ed.)
N2aCutaneous Melanoma pN2a TNM Finding v7Cutaneous melanoma with micrometastases in 2-3 regional lymph nodes. Micrometastases are diagnosed after sentinel lymph node biopsy and completion of lymphadenectomy (if performed). (from AJCC 7th Ed.)
N2bCutaneous Melanoma pN2b TNM Finding v7Cutaneous melanoma with macrometastases in 2-3 regional lymph nodes. Macrometastases are defined as clinically detectable nodal metastases confirmed by therapeutic lymphadenectomy or when nodal metastasis exhibits gross extracapsular extension. (from AJCC 7th Ed.)
N2cCutaneous Melanoma pN2c TNM Finding v7Cutaneous melanoma with intralymphatic metastases (in transit or satellite metastases) without metastatic nodes. (from AJCC 7th Ed.)
N3Cutaneous Melanoma pN3 TNM FindingCutaneous melanoma involving four or more regional lymph nodes, or with a finding of matted metastatic nodes, or with in-transit metastasis or satellite(s) with metastasis in regional lymph node(s). (from AJCC 6th and 7th Eds.)
Pathologic M StageCutaneous Melanoma American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Distant Metastasis M Stage33576421.0CHARACTER
M1aCutaneous Melanoma pM1a TNM Finding v7Cutaneous melanoma with metastases to skin, subcutaneous tissues, or distant lymph nodes associated with normal serum lactate dehydrogenase (LDH). (from AJCC 7th Ed.)
M1bCutaneous Melanoma pM1b TNM Finding v7Cutaneous melanoma with metastases to lung associated with normal serum lactate dehydrogenase (LDH). (from AJCC 7th Ed.)
M1cCutaneous Melanoma pM1c TNM FindingCutaneous melanoma with metastases to all other visceral sites associated with normal serum lactate dehydrogenase (LDH) or distant metastases to any site associated with an elevated serum LDH. (from AJCC 6th and 7th Eds.)
Disease StageCutaneous Melanoma American Joint Committee on Cancer (AJCC) Edition 7 Group Stage33576431.0CHARACTER
0Stage 0 Skin MelanomaStage 0 includes: Tis, N0, M0. Tis: Melanoma in situ. N0: No regional lymph node metastases. M0: No detectable evidence of distant metastases. (from AJCC 6th and 7th Eds.)
IAStage IA Skin MelanomaStage IA includes: T1a, N0, M0. T1a: Cutaneous melanoma with a tumor measuring 1.0 mm or less in thickness, without ulceration and with mitosis less than 1/mm2. N0: No regional lymph node metastases. M0: No detectable evidence of distant metastases. (from AJCC 7th Ed.)
IBStage IB Skin MelanomaStage IB includes: (T1b, N0, M0); (T2a, N0, M0). T1b: Cutaneous melanoma with a tumor measuring 1.0 mm or less in thickness, with ulceration or mitoses equal or more than 1/mm2. T2a: Cutaneous melanoma with a tumor measuring 1.01-2.0 mm in thickness, without ulceration. N0: No regional lymph node metastases. M0: No detectable evidence of distant metastases. (from AJCC 7th Ed.)
IIAStage IIA Skin MelanomaStage IIA includes: (T2b, N0, M0); (T3a, N0, M0). T2b: Cutaneous melanoma with a tumor measuring 1.01-2.0 mm in thickness, with ulceration. T3a: Cutaneous melanoma with a tumor measuring 2.01-4.0 mm in thickness, without ulceration. N0: No regional lymph node metastases. M0: No detectable evidence of distant metastases. (from AJCC 6th and 7th Eds.)
IIBStage IIB Skin MelanomaStage IIB includes: (T3b, N0, M0); (T4a, N0, M0). T3b: Cutaneous melanoma with a tumor measuring 2.01-4.0 mm in thickness, with ulceration. T4a: Cutaneous melanoma with a tumor measuring more than 4.0 mm in thickness, without ulceration. N0: No regional lymph node metastases. M0: No detectable evidence of distant metastases. (from AJCC 6th and 7th Eds.)
IICStage IIC Skin MelanomaStage IIC includes: T4b, N0, M0. T4b: Cutaneous melanoma with a tumor measuring more than 4.0 mm in thickness, with ulceration. N0: No regional lymph node metastases. M0: No detectable evidence of distant metastases. (from AJCC 6th and 7th Eds.)
IIIStage III Skin MelanomaStage III includes: Any T, N1-3, M0. Stage III is divided into three pathologic subgroups: IIIA, IIIB, and IIIC. There are no clinical subgroups for stage III. N1: Cutaneous melanoma with metastasis in one regional lymph node. N2: Cutaneous melanoma with metastases in 2-3 regional lymph nodes or in transit met(s)/satellite(s) without metastatic nodes. N3: Cutaneous melanoma with 4 or more metastatic nodes, or matted nodes, or in transit met(s)/satellite(s) with metastatic node(s). M0: No detectable evidence of distant metastases. (from AJCC 7th Ed.)
IIIAStage IIIA Skin MelanomaStage IIIA includes: (T1-4a, N1a, M0); (T1-4a, N2a, M0). T1-4a: Non-ulcerated cutaneous melanoma of any thickness. N1a: Cutaneous melanoma with micrometastasis in one regional lymph node. N2a: Cutaneous melanoma with micrometastases in 2-3 regional lymph nodes. M0: No detectable evidence of distant metastases. (from AJCC 7th Ed.)
IIIBStage IIIB Skin MelanomaStage IIIB includes: (T1-4b, N1a, M0); (T1-4b, N2a, M0); (T1-4a, N1b, M0); (T1-4a, N2b, M0); (T1-4a, N2c, M0). T1-4b: Ulcerated cutaneous melanoma of any thickness. T1-4a: Non-ulcerated cutaneous melanoma of any thickness. N1a: Cutaneous melanoma with micrometastasis in one regional lymph node. N2a: Cutaneous melanoma with micrometastases in 2-3 regional lymph nodes. N1b: Cutaneous melanoma with macrometastasis in one regional lymph node. N2b: Cutaneous melanoma with macrometastases in 2-3 regional lymph nodes. N2c: Cutaneous melanoma with intralymphatic metastases (in transit or satellite metastases) without metastatic nodes. M0: No detectable evidence of distant metastases. (from AJCC 7th Ed.)
IIICStage IIIC Skin MelanomaStage IIIC includes: (T1-4b, N1b, M0); (T1-4b, N2b, M0); (T1-4b, N2c, M0); (Any T, N3, M0). T1-4b: Ulcerated cutaneous melanoma of any thickness. N1b: Cutaneous melanoma with macrometastasis in one regional lymph node. N2b: Cutaneous melanoma with macrometastases in 2-3 regional lymph nodes. N2c: Cutaneous melanoma with intralymphatic metastases (in transit or satellite metastases) without metastatic nodes. N3: Cutaneous melanoma with 4 or more metastatic nodes, or matted nodes, or in transit met(s)/satellite(s) with metastatic node(s). M0: No detectable evidence of distant metastases. (from AJCC 7th Ed.)
IVStage IV Skin MelanomaStage IV includes: (Any T, Any N, M1). M1: Distant metastasis. (from 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.
Optional Cutaneous Melanoma 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)