Melanoma (Skin) Clinical Trial
Official title:
A Retrospective Case-Control Study of Melanoma Patients Who Have Undergone Sentinel Lymph Node Biopsy
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.
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.
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N/A
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