Collecting Tissue Samples From Patients With Melanocytic Nevi or Pigmented Lesions - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00335530

Purpose

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.

Condition	Intervention
Melanoma (Skin) Precancerous/Nonmalignant Condition	Procedure: biopsy

MedlinePlus related topics: Melanoma Moles

U.S. FDA Resources

Study Type:	Observational
Official Title:	Dermoscopic Diagnosis, Histopathological Correlation, and Cellular Immortalization of Melanocytic Nevi and Primary Cutaneous Melanoma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	110
Study Start Date:	February 2006

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Meets 1 of the following criteria:
- Children ≤ 5 years of age meeting the following criteria:
  - Histologically confirmed or clinically diagnosed large congenital melanocytic nevi
    - Must be > 20 cm in any 1 dimension OR > 8 cm in any 1 dimension involving the scalp
- Adults > 18 years of age meeting 1 of the following criteria:
  - Must have ≥ 100 melanocytic nevi > 2 mm in diameter AND ≥ 1 melanocytic nevus ≥ 4 mm in longest dimension
    - Prior history of cutaneous or ocular malignant melanoma allowed
  - Pigmented lesion clinically suspicious for primary melanoma
No genetic syndrome associated with multiple lentigines or nevi (e.g., Peutz-Jeghers syndrome, Carney complex, Turner syndrome, or Noonan's syndrome)
No more than 1 first-degree relative with a history of cutaneous melanoma and familial atypical mole-melanoma syndrome phenotype
No cancer-associated syndrome (e.g., xeroderma pigmentosum, type 1 neurofibromatosis, or Li-Fraumeni syndrome)
No metastatic melanoma

PATIENT CHARACTERISTICS:

Must have outside primary physician
Able to tolerate surgical procedure
No bleeding diathesis, coagulopathy, or excessive bleeding tendency

PRIOR CONCURRENT THERAPY:

No recent chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335530

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Thomas J. Hornyak, MD, PhD

NCI - Dermatology Branch

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000467976, NCI-06-C-0060, NCI-P6555
Study First Received:	June 8, 2006
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00335530
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

melanoma
precancerous/nonmalignant condition

Study placed in the following topic categories:

Neuroectodermal Tumors
Precancerous Conditions
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Melanoma, familial

Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009