Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy
Recruitment status was: Recruiting
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.
Genetic: gene expression analysis
Genetic: mutation analysis
Other: diagnostic laboratory biomarker analysis
Other: immunohistochemistry staining method
Procedure: sentinel lymph node biopsy
|Official Title:||A Retrospective Case-Control Study of Melanoma Patients Who Have Undergone Sentinel Lymph Node Biopsy|
- Predictive model for sentinel lymph node biopsy positivity [ Designated as safety issue: No ]
- Survival model for relapse [ Designated as safety issue: No ]
- Genetic determinants in primary melanomas that predict a metastatic phenotype [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897481
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Study Chair:||Julia Newton Bishop, MD||Leeds Cancer Centre at St. James's University Hospital|