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

Leeds Cancer Centre at St. James's University Hospital

Status: Unknown

Conditions: Melanoma (Skin)

Treatments: Genetic: gene expression analysis; Genetic: mutation analysis; Other: immunohistochemistry staining method; Other: diagnostic laboratory biomarker analysis; Procedure: sentinel lymph node biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT00897481

CRUK-LCC-06/Q1206/149

EU-20706

CDR0000532943 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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