Collecting Tissue Samples From Patients With Melanocytic Nevi or Pigmented Lesions

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


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.




- 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.


- 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



Melanoma (Skin)


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


Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
United States




National Cancer Institute (NCI)

Results (where available)

View Results


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

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