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

Melanoma (Skin) Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

• NCT number: NCT00049010
• Study type: Interventional
• Source: Alliance for Clinical Trials in Oncology
• Status: Completed
• Phase: N/A
• Start date: September 2002
• Completion date: October 2009