Trial Information

A Retrospective Case-Control Study of Melanoma Patients 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.