Protocol Number: 06-C-0060

Title:

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

Number:

06-C-0060

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)

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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.

OR

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.

OR

Adults

Must be greater than 18 years.

Must have a current pigmented lesion clinically suspicious for primary melanoma.

Must have outside primary physician.

AND

All patients, or in the case of infants and children their parents or legal guardians, must be able to understand and sign an informed consent.

EXCLUSION CRITERIA:

The patient does not meet the inclusion criteria.

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.

Special Instructions:

Currently Not Provided

Keywords:

Suspicious mole

Congenital Nevus

Skin Cancer

Moles

Pigmented lesion

Recruitment Keyword(s):

Congenital Nevus

Moles

LCMN

Suspicious mole

Condition(s):

Melanocytic Nevi

Acquired Melanocytic Nevi

Primary Cutaneous Melanoma

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

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.

Chromosomal gains and losses in primary cutaneous melanomas detected by comparative genomic hybridization.Cancer Res. 1998 May 15;58(10):2170-5.

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.

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