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M3: Genetic Risk Factors and Acquired Oncogenic Mutations of Melanoma

Sponsor
Medical University of Vienna (Other)
Overall Status
Unknown status
CT.gov ID
NCT00849407
Collaborator
(none)
2,000
Enrollment
1
Location
146
Duration (Months)
13.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Though it is generally accepted that exposure to sunlight is a major causative factor for skin cancer, the risk for developing melanoma is not directly linked to sun exposure such as in non-melanoma skin cancer. Therefore, a dual pathway has been proposed, distinguishing melanoma that develops on skin that is chronically exposed to sunlight from those that occur on skin that is normally protected. The risk for each type of melanoma is believed to be determined in part by genetic factors. To define these markers reproducibly, the investigators plan to establish a large cohort with comprehensive information regarding sun sensitivity (skin type), history of experienced sun exposure, skin pigmentation phenotypes, total number of nevi, and other types of skin tumors in a central European population. The investigators will obtain blood from all participants for DNA as well as serum analyses. Based on the finding that genetic variants of the melanocortin-1 receptor (MC1R) gene, associated with red hair and fair skin, have been shown to be associated with increased risk for melanoma, particularly those harboring BRAF mutations, the investigators will now focus on the study of recently discovered genetic variants associated with pigmentation. Furthermore, the investigators will study the relation of these variants with oncogenic mutations of melanoma in BRAF, RAS and c-Kit. The study of other genetic variants will follow, once a sufficiently large cohort has been established to reveal an independent genetic risk factor in a multivariate analysis including potential covariates as mentioned above. The identification of genetic risk factors for melanoma will not only help identify individuals with increased risk but also improve our understanding of the molecular background of the development of melanoma.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Genetic Risk Factors and Acquired Oncogenic Mutations of Melanoma
    Study Start Date :
    Oct 1, 2008
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    1

    melanoma patients
    2

    controls

    Outcome Measures

    Primary Outcome Measures

    1. melanoma [2 years]

    Secondary Outcome Measures

    1. survival [10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients with or without melanoma
    Exclusion Criteria:
    • HIV and Hepatitis C positive individuals.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Vienna Vienna Austria A-1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ichiro Okamoto, associate professor, Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT00849407
    Other Study ID Numbers:
    • M3-I
    First Posted:
    Feb 23, 2009
    Last Update Posted:
    Mar 7, 2019
    Last Verified:
    Mar 1, 2019
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Mar 7, 2019