Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy
|ClinicalTrials.gov Identifier: NCT00897481|
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 12, 2009
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment|
|Melanoma (Skin)||Genetic: gene expression analysis Genetic: mutation analysis Other: diagnostic laboratory biomarker analysis Other: immunohistochemistry staining method Procedure: sentinel lymph node biopsy|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||A Retrospective Case-Control Study of Melanoma Patients Who Have Undergone Sentinel Lymph Node Biopsy|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||September 2011|
- Predictive model for sentinel lymph node biopsy positivity
- Survival model for relapse
- Genetic determinants in primary melanomas that predict a metastatic phenotype
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897481
|Leeds Cancer Centre at St. James's University Hospital||Recruiting|
|Leeds, England, United Kingdom, LS9 7TF|
|Contact: Julia Newton Bishop, MD 44-113-206-4668|
|Study Chair:||Julia Newton Bishop, MD||Leeds Cancer Centre at St. James's University Hospital|