Natural History Study of Moles and Suspicious Melanoma

NCT00288938 | Completed

• 2 other identifiers: 06006006-C-0060
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• Melanocytic nevi, or "moles," are non-cancerous growths of a type of skin cell called a melanocyte.
• Large congenital melanocytic nevi (LCMN) are a special type of mole that begins to grow before birth and is larger than moles that develop after birth.
• Determining how melanocytes in moles and LCMNs differ from normal melanocytes may increase the ability to predict whether a mole will give rise to a melanoma (a type of skin cancer) Objectives:
• To understand how melanomas develop, by studying moles, LCMNs, and pigmented skin lesions that are suspicious for melanoma
• To develop better criteria for diagnosing melanoma, particularly by using a device called a digital dermatoscope (a special camera, connected to a computer, that takes pictures of moles when they are magnified and illuminated) Eligibility:
• Children 5 years old or older with an LCMN
• Adults 18 years old or older with 100 or more moles larger than 2 mm in diameter and at least one 4 mm or more
• Adults 18 years old or older with a pigmented lesion suspicious for melanoma Design:
• Patients' personal and family health history is obtained.
• Patients are examined by investigative team doctors, and several lesions are examined with a dermatoscope.
• Additional photographs of part or all of the skin surface may be taken.
• Some lesions may be biopsied.
• Additional tests or examinations may be recommended.
• Patients are followed periodically for skin or physical examinations, photography, laboratory and imaging evaluations, and possible skin biopsies.
• Children may undergo brain magnetic resonance imaging (MRI)

Conditions

Melanocytic Nevi; Acquired Melanocytic Nevi; Primary Cutaneous Melanoma

Keywords

Suspicious mole; Congenital Nevus; Skin Cancer; Moles; Pigmented lesion; LCMN

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants/Children
• Must be less than or equal to 5 years.
• Must have large congenital melanocytic nevus (LCMN, diagnosed clinically or by biopsy) that is greater than 20 cm in any one dimension or that is greater than 8 cm in any one dimension involving the scalp.
• Must have outside referring physician.
• Adults
• Must be greater than 18 years.
• Must have greater than or equal to 100 melanocytic nevi greater than 2 mm in diameter.
• Must have at least one melanocytic nevus greater than or equal to 4 mm in longest dimension.
• Can have prior history of cutaneous or ocular malignant melanoma.
• Must have outside primary physician.
• Adults
• Must be greater than 18 years.
• Must have a current pigmented lesion clinically suspicious for primary melanoma.
• Must have outside primary physician.
• AND

You may not qualify if:

• Diagnosis of genetic syndrome associated with multiple lentigines or nevi (Peutz-Jeghers syndrome, Carney complex, turner syndrome, Noonan's syndrome).
• Two or more first-degree relatives with history of cutaneous melanoma and familial atypical mole-melanoma syndrome phenotype.
• Diagnosis of cancer-associated syndrome (xeroderma pigmentosum, type I neurofibromatosis, Li-Fraumeni syndrome).
• Inability to tolerate surgical procedure due to bleeding diathesis or disorder or other cause as determined by principal investigator.
• Patient is unwilling to consider elective biopsy of a melanocytic nevus.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Bastian BC, Kashani-Sabet M, Hamm H, Godfrey T, Moore DH 2nd, Brocker EB, LeBoit PE, Pinkel D. Gene amplifications characterize acral melanoma and permit the detection of occult tumor cells in the surrounding skin. Cancer Res. 2000 Apr 1;60(7):1968-73.

  PMID: 10766187 BACKGROUND

• Bastian BC, LeBoit PE, Hamm H, Brocker EB, Pinkel D. Chromosomal gains and losses in primary cutaneous melanomas detected by comparative genomic hybridization. Cancer Res. 1998 May 15;58(10):2170-5.

  PMID: 9605762 BACKGROUND

• Bataille V, Grulich A, Sasieni P, Swerdlow A, Newton Bishop J, McCarthy W, Hersey P, Cuzick J. The association between naevi and melanoma in populations with different levels of sun exposure: a joint case-control study of melanoma in the UK and Australia. Br J Cancer. 1998;77(3):505-10. doi: 10.1038/bjc.1998.81.

  PMID: 9472652 BACKGROUND

MeSH Terms

Conditions

Nevus, Pigmented; Skin Neoplasms; Nevus

Condition Hierarchy (Ancestors)

Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 8, 2006
• First Posted: February 8, 2006
• Study Start: February 3, 2006
• Study Completion: October 31, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-10-31

Locations

US (1)