Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy

Study Overview
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Brief Summary
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RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future. PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy.

Detailed Description
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OBJECTIVES: Develop a predictive model for sentinel lymph node biopsy positivity in patients with melanoma who have undergone sentinel lymph node biopsy. Develop a survival model for relapse based on sentinel lymph node biopsy positivity. Assess the genetic determinants in primary melanomas that predict a metastatic phenotype and thereby improve understanding of the biology of the metastases in melanoma. OUTLINE: This is a retrospective, case-controlled, multicenter study. Patients are stratified according to Breslow thickness of the tumor (0.75-1.50 mm vs 1.51- 4 mm vs > 4 mm) and gender. Archived tumor tissue is analyzed by immunohistochemistry (IHC) for AP2, vascular endothelial growth factor, MMP 2, MCM4, and others, if feasible. Sentinel node biopsies are analyzed by IHC for CD31, LYVE-1, and D2-40 expression. RNA and DNA are also extracted for genetic expression studies and mutation analysis (e.g., BRAF, NRAS, PTEN, CDKN2A). Patient data related to relapse and recurrence is collected, if available. Peer reviewed and funded or endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Official Title
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A Retrospective Case-Control Study of Melanoma Patients Who Have Undergone Sentinel Lymph Node Biopsy

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: mutation analysis
* Other: diagnostic laboratory biomarker analysis
* Other: immunohistochemistry staining method
* Procedure: sentinel lymph node biopsy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Confirmed diagnosis of cutaneous melanoma Breslow thickness > 0.75 mm Has undergone sentinel lymph node biopsy No primary melanoma that has not originated in the skin No multiple primary melanomas Currently under clinical followup OR discharged from follow up within the past 3 months PATIENT CHARACTERISTICS: No other malignancy except for nonmelanoma skin cancer or cervical carcinoma in situ PRIOR CONCURRENT THERAPY: See Disease Characteristics
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: mutation analysis|nan|
|Other: diagnostic laboratory biomarker analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Procedure: sentinel lymph node biopsy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive model for sentinel lymph node biopsy positivity |  |  | 
| Survival model for relapse |  |  | 
| Genetic determinants in primary melanomas that predict a metastatic phenotype |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma, stage IA melanoma, stage IB melanoma, stage IIA melanoma, stage IIB melanoma, stage IIC melanoma, stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma