Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00040352
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
4 Weeks - 99 Years
Healthy Volunteers
Accepted

Study Details

This study will investigate how genetic and environmental factors contribute to the development of melanoma, a type of skin cancer, and related conditions. Individuals \>=4 weeks with a personal or family history of melanoma or atypical spitzoid/Spitz tumor may be eligible for this study. Participants will: * Fill out one or two questionnaires about their personal and family medical history. * Provide written consent for researchers to review their medical records and pathology materials related to their care and those of deceased relatives with melanomas, tumors, cancer, or other related illnesses for whom they are the next-of-kin or legally authorized representative. * Donate a blood or cheek cell sample to be used for genetic studies. (The blood sample is collected through a needle in an arm vein. The cheek cell sample is obtained either by gently brushing the inside of the mouth with a soft brush or by swishing a tablespoon of mouthwash and then spitting it into a container.) * Undergo a skin biopsy (removal of a small piece of skin tissue) for genetic study. For this procedure, the area of skin to be removed is numbed with a local anesthetic and a 1/4-inch piece of skin is excised with a cookie cutter-like instrument. The wound is then covered with a band-aid. Participants may be asked to travel to the NIH Clinical Center for evaluation, including a medical history, physical examination, and some of the following procedures: * Full body skin examination to evaluate the type and number of moles and document any evidence of sun damage to the skin. The examination involves all the skin from the scalp to the bottoms of the feet. After the examination, a medical photographer will photograph the skin, with close-ups of skin lesions marked by the examiner. If there are parts of the skin the participant does not want examined or photographed, he or she can tell the examiner. * Blood draw of about 120 milliliters (4 ounces) or less * Skin biopsy * Cheek cell sample * X-rays, ultrasound and magnetic resonance imaging (MRI) studies to detect tumors or changes in tumors or other types of changes in specific tissues. MRI is a diagnostic test that uses strong magnetic fields and radiowaves to examine body tissues. The subject lies on a table that is moved into a large tunnel-like machine (the scanner) for about 45 minutes to 1 hour. When the tests are finished, a doctor will discuss the results with the participant and the need, if any, for clinical follow-up.

Key Dates

Start date
Jul 1, 2002
Status verified
Jun 2026

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: Affected Individual
    An individual with personal medical history of melanoma of an unusual type, pattern, or number, a known or suspected condition predisposing to melanoma, either genetic or congenital factors (giant congenital nevi, dysplastic nevi, Spitzoid tumors), or unusual demographic features, or any of the other criteria noted in Section 4.1 of the protocol
  • Arm: Unaffected individual
    A family member of an affected participant. Family members may include parents, siblings, children or extended family.

Primary Outcome Measure

All cancers that occur in individuals and families at high risk of melanoma [ Time Frame: Ongoing ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
National Cancer Institute (NCI)BethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

Find similar trials in Bethesda, MD

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
National Cancer Institute (NCI)· Bethesda, MDNational Institutes of Health Clinical Center· Bethesda, MD

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