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Collecting Tissue Samples From Patients With Melanocytic Nevi or Pigmented Lesions

2014-08-27 03:44:14 | BioPortfolio

Summary

RATIONALE: Collecting and storing tissue samples from patients with melanocytic nevi or pigmented lesions to study in the laboratory may help doctors learn more about the development of melanoma.

PURPOSE: This clinical trial is collecting and storing tissue samples to study in the laboratory from patients with melanocytic nevi or pigmented lesions.

Description

OBJECTIVES:

Primary

- Obtain tissue from benign melanocytic nevi and LCMN for experimental study.

- Refine culture and immortalization methods for melanocytes derived from melanocytic nevi that permits in vitro expansion of these cells for functional study.

- Correlate clinical and dermoscopic observations of primary melanoma with histopathology to establish standards for sampling primary melanoma in a possible future study.

Secondary

- Obtain, prospectively, a set of tissue samples of melanocytic nevi and primary melanoma with detailed clinical information for evaluating novel diagnostic techniques and for the basis of a nevus/primary melanoma tissue microarray.

OUTLINE: Patients are stratified according to diagnosis (children ≤ 5 years of age with large congenital melanocytic nevi vs adults with ≥ 100 acquired melanocytic nevi vs adults with suspected primary melanoma).

Patients undergo extensive full-body photography to document the number, type, and location of melanocytic nevi and pigmented lesions. Patients will also undergo excisional or staged (incisional and excisional) biopsy* of the melanocytic nevi or pigmented lesions. Dermoscopic images are performed before and after biopsy* on both clinically benign melanocytic nevi and pigmented lesions that are clinically suspicious for primary melanoma. Patients with a diagnosis of malignant melanoma receive standard care for primary melanoma.

NOTE: *Patients with lesions < 4 mm OR lesions 4-6 mm with ≤ 1-axis symmetry do not undergo biopsy.

Biopsy tissue will be used for immortalization of nevus-derived melanocytes and mutation screening (e.g., somatic mutations at codon 599 of BRAF and codon 61 of NRAS) and functional studies (e.g., gene expression analysis) of nevus-derived melanocytes.

Patients diagnosed with malignant melanoma and < 100 acquired melanocytic nevi are followed every 6 months for ≥ 2 years and then annually for ≥ 3 years. All other patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study.

Study Design

N/A

Conditions

Melanoma (Skin)

Intervention

gene expression analysis, mutation analysis, biologic sample preservation procedure, biopsy, diagnostic imaging technique

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda
Maryland
United States
20892-1182

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:14-0400

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