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

StatusRecruiting
PhaseNot specified
Started

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Record History

The 50 most recent of 299 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Minor Eligibility criteria expanded, about 13 words
  4. 2 versions Re-verified since Sep 2, 2026, no change to tracked fieldsv295-v296
  5. Minor Eligibility criteria shortened, about 2 wordsv294
Show 44 earlier versionsHide 44 earlier versions
  1. 30 versions Re-verified since May 2, 2025, no change to tracked fieldsv264-v293
  2. Study Status, Conditions, Arms and Interventions, Eligibilityv263
  3. 3 versions Re-verified since Mar 10, 2025, no change to tracked fieldsv260-v262
  4. Study Status, Eligibilityv259
  5. 9 versions Re-verified since Oct 9, 2024, no change to tracked fieldsv250-v258
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00040352
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)
Melanoma, Dysplastic Nevus Syndrome
Related terms Dysplastic Nevus Syndrome, Melanoma, Skin Neoplasms
Enrollment 3,000 participants
Start Date
Updated on ClinicalTrials.gov