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

Melanoma (Skin) Clinical Trial

Official title:

A Retrospective Case-Control Study of Melanoma Patients Who Have Undergone Sentinel Lymph Node Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00897481
• Other study ID #: CRUK-LCC-06/Q1206/149
• Secondary ID: CDR0000532943EU-
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: August 9, 2013
• Start date: January 2007

Study information

• Verified date: April 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Genetic:
• gene expression analysis

• mutation analysis

Other:
• diagnostic laboratory biomarker analysis

• immunohistochemistry staining method

Procedure:
• sentinel lymph node biopsy

Locations

Country	Name	City	State
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England

Sponsors (1)

Lead Sponsor	Collaborator
Leeds Cancer Centre at St. James's University Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive model for sentinel lymph node biopsy positivity			No
Primary	Survival model for relapse			No
Primary	Genetic determinants in primary melanomas that predict a metastatic phenotype			No