Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00040352 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

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

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Re-verified, no change to tracked fields

  3. Minor

    Eligibility criteria expanded, about 13 words

    Study description expanded, about 9 words; Publications: details revised at 6 of 6 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: * On referral, persons \>=4 weeks old of any sex, race or ethnicity will be consider [...] 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, eithe [...] lymphoma, immunodeficiency syndrome, or organ transplant). * Ability of the individual or their parent or legal guardian, [...] erstand, and their willingness to [...]
    Show what changed: Study description
    [...] programs aimed at early diagnosis of melanoma. Objectives: 1. To evaluate and define the clinical spectrum and natural history of disease in syndromes predisposing to melanoma 2. To evaluate potential precursor states of disease in individuals and families at risk 3. To quantify risks of melanoma, pancreatic cancer, and other [...] members and individuals with an elevated risk for melanoma 4. To map, clone, and determine function of tumor susceptibilit [...] odifier genes such as pigmentation or dysplastic nevi genes 5. To identify genetic determinants and gene-environmental inte [...] elanoma (and other cancer [...]

  4. Minor

    2 amendments

    2 re-verifications since 2026-09-02, no change to tracked fields

    v295-v296

  5. Minor

    Eligibility criteria shortened, about 2 words

    Show what changed: Eligibility criteria
    [...] nomas, previous history of heritable retinoblastoma, Hodgkin's disease, lymphoma, immunodeficiency syndrome, or organ tra [...] nomas, previous history of heritable retinoblastoma, Hodgkin's disease, lymphoma, immunodeficiency syndrome, or organ tra [...]

    Study Status, Eligibilityv294

Show 44 earlier versions

  1. Minor

    30 amendments

    30 re-verifications since 2025-05-02, no change to tracked fields

    v264-v293

  2. Minor

    Study Status, Conditions, Arms and Interventions, Eligibility

    v263

  3. Minor

    3 amendments

    3 re-verifications since 2025-03-10, no change to tracked fields

    v260-v262

  4. Minor

    Eligibility criteria revised

    Show what changed: Eligibility criteria
    INCLUSION CRITERIA: On referral, persons >=4 weeks old of any gendersex, race or ethnicity will be considered for inclusion in the [...]

    Study Status, Eligibilityv259

  5. Minor

    9 amendments

    9 re-verifications since 2024-10-09, no change to tracked fields

    v250-v258

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • 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 Melanoma, Dysplastic Nevus Syndrome
Enrollment 3,000 participants
Start Date
Updated on ClinicalTrials.gov