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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897481
First received: May 9, 2009
Last updated: August 9, 2013
Last verified: April 2008

May 9, 2009
August 9, 2013
January 2007
September 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00897481 on ClinicalTrials.gov Archive Site
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Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy
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.

Observational
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Melanoma (Skin)
  • Genetic: gene expression analysis
  • Genetic: mutation analysis
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunohistochemistry staining method
  • Procedure: sentinel lymph node biopsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
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September 2011   (final data collection date for primary outcome measure)

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
Both
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No
United Kingdom
 
NCT00897481
CRUK-LCC-06/Q1206/149, CDR0000532943, EU-20706
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Leeds Cancer Centre at St. James's University Hospital
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Study Chair: Julia Newton Bishop, MD Leeds Cancer Centre at St. James's University Hospital
National Cancer Institute (NCI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP