Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
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.
Genetic: comparative genomic hybridization
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization
Other: immunohistochemistry staining method
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Diagnostic
|Official Title:||Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma|
- Correlation of melastatin expression and involvement of local regional lymph nodes by pathology prospectively [ Designated as safety issue: No ]
- Relapse-free survival based on visits to medical doctor every 4 months [ Designated as safety issue: No ]
|Study Start Date:||September 2002|
|Study Completion Date:||October 2009|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
- 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.