Collecting Tissue Samples From Patients With Melanocytic Nevi or Pigmented Lesions



Status:Archived
Conditions:Skin Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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Dermoscopic Diagnosis, Histopathological Correlation, and Cellular Immortalization of Melanocytic Nevi and Primary Cutaneous Melanoma


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.


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.


We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
1-800-422-6237
National Cancer Institute (NCI) The National Cancer Institute (NCI) is part of the National Institutes...
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Bethesda, MD
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