Melanoma Clinical Trial
Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
Summary
RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer.
PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage I or stage II melanoma.
Full Description
OBJECTIVES:
Correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage I or II melanoma.
Correlate melastatin expression prospectively with event-free survival of these patients.
OUTLINE: This is a multicenter study.
Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.
Patients are followed every 4 months for 3.5 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 3.5 years.
Eligibility Criteria
Histologically documented primary AJCC stage I or II melanoma. Evidence of ulceration, vertical growth phase, regression, lymphocytic infiltration, vascular invasion, microscopic satellitosis, and mitotic rate shall be noted.
Patients planning to undergo a sentinel lymph node biopsy, or an elective lymph node dissection of an anatomic draining region from the index primary melanoma.
≥18 years of age
Patients must be registered prior to planned surgery. The surgery must be performed within 45 days following registration.
No concurrent active malignancy other than carcinoma in situ of the cervix and basal cell carcinoma of the skin, or history of any other primary malignancy including previously primary melanoma.
Tissue blocks: one of primary tumor tissue taken from region of greatest Breslow thickness. Note: If blocks cannot be sent due to institutional policy, slides may be substituted for the locks per the protocol.
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There are 24 Locations for this study
Chicago Illinois, 60637, United States
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Iowa, 52403, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
Worcester Massachusetts, 01605, United States
Minneapolis Minnesota, 55455, United States
Columbia Missouri, 65203, United States
Jefferson City Missouri, 65101, United States
Keene New Hampshire, 03431, United States
Lebanon New Hampshire, 03756, United States
Glens Falls New York, 12801, United States
New York New York, 10021, United States
Syracuse New York, 13057, United States
Syracuse New York, 13215, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Wilson North Carolina, 27893, United States
Winston-Salem North Carolina, 27157, United States
Providence Rhode Island, 02903, United States
Providence Rhode Island, 02906, United States
Charleston South Carolina, 29401, United States
Berlin Vermont, 05602, United States
Burlington Vermont, 05401, United States
Danville Virginia, 24541, United States
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