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Search / Trial NCT00040352

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jun 25, 2002

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Skin Cancer Risk Factors Melanoma Precursors Genetics Melanoma

ClinConnect Summary

This clinical trial is focused on understanding the factors that lead to melanoma, a type of skin cancer, particularly in individuals and families who may be at higher risk. Researchers are looking into how both genetic (inherited) and environmental factors contribute to the development of melanoma and related conditions. If you or a family member has a history of melanoma or certain unusual skin tumors, you might be eligible to participate in this study.

Participants will be asked to complete questionnaires about their medical history, provide samples of blood or cheek cells for genetic testing, and undergo skin examinations and biopsies. The study may involve traveling to the NIH Clinical Center for a full evaluation, which includes a detailed skin check and imaging tests like MRIs to look for tumors. After these procedures, a doctor will discuss the results with you and any necessary follow-up care. This trial is open to individuals aged 4 weeks and older, regardless of gender or ethnicity, who have either a personal or family history of melanoma or related conditions.

Gender

ALL

Eligibility criteria

  • * INCLUSION CRITERIA:
  • On referral, persons \>=4 weeks old of any sex, race or ethnicity will be considered for inclusion in the study because of the criteria noted below.
  • * Affected: An individual who meets any of the following criteria will be eligible to participate in this study:
  • personal medical history of melanoma of an unusual type, pattern, or number diagnosed at any age; or,
  • known or suspected factor(s) predisposing to melanoma, either genetic or congenital factors (giant congenital nevi, dysplastic nevi, Spitzoid tumors), or unusual demographic features (e.g., very young age of onset, multiple melanomas, previous history of heritable retinoblastoma, Hodgkin s disease, lymphoma, immunodeficiency syndrome, or organ transplant).
  • Ability of the individual or their parent or legal guardian, to understand, and their willingness to provide informed consent.
  • * Unaffected: An individual who meets any of the following criteria will be eligible to participate in this study:
  • family medical history of melanoma of an unusual type, pattern, or number; or,
  • known or suspected factor(s) predisposing to melanoma, either genetic or congenital factors (giant congenital nevi, dysplastic nevi. Spitzoid tumors), or unusual demographic features (e.g., very young age of onset, multiple melanomas, previous history of heritable retinoblastoma, Hodgkin s disease, lymphoma, immunodeficiency syndrome, or organ transplant).
  • Ability of the individual or their parent, or legal guardian to understand, and their willingness to provide informed consent.
  • Personal and family medical history must be verified through questionnaires, interviews, and review of pathology slides and medical records.
  • EXCLUSION CRITERIA:
  • Referred individuals and families for whom reported diagnoses cannot be verified;
  • Inability to provide informed consent

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

Patients applied

BB

RN

CG

3 patients applied

Trial Officials

Michael R Sargen, M.D.

Principal Investigator

National Cancer Institute (NCI)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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