NCT00049010

Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma

Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
GENETIC	comparative genomic hybridization
GENETIC	cytogenetic analysis
GENETIC	fluorescence in situ hybridization
OTHER	immunohistochemistry staining method

Timeline

• Start date: 2002-09-01
• Primary completion: 2006-03-01
• Completion: 2009-10-01
• First posted: 2003-01-27
• Last updated: 2016-07-01

Locations

27 sites across 1 country: United States