Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
- Conditions
- Melanoma (Skin)
- Interventions
- Genetic: comparative genomic hybridizationGenetic: cytogenetic analysisGenetic: fluorescence in situ hybridizationOther: immunohistochemistry staining method
- Registration Number
- NCT00049010
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 314
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 fluorescence in situ hybridization 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. Group 1 immunohistochemistry staining method 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. Group 1 comparative genomic hybridization 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. Group 1 cytogenetic analysis 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.
- Primary Outcome Measures
Name Time Method Relapse-free survival Up to 3.5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Iowa Blood and Cancer Care
🇺🇸Cedar Rapids, Iowa, United States
Commonwealth Hematology-Oncology P.C. - Worcester
🇺🇸Worcester, Massachusetts, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
🇺🇸Keene, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
🇺🇸Glens Falls, New York, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸Syracuse, New York, United States
Community General Hospital of Greater Syracuse
🇺🇸Syracuse, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Fairview University Medical Center - University Campus
🇺🇸Minneapolis, Minnesota, United States
St. Luke's Hospital
🇺🇸Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Wilson Medical Center
🇺🇸Wilson, North Carolina, United States
Wayne Radiation Oncology
🇺🇸Goldsboro, North Carolina, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Miriam Hospital at Lifespan
🇺🇸Providence, Rhode Island, United States
Roper St. Francis Cancer Center at Roper Hospital
🇺🇸Charleston, South Carolina, United States
Mountainview Medical
🇺🇸Berlin, Vermont, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Capital Region Cancer Center
🇺🇸Jefferson City, Missouri, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States