Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors

Sponsor
Rutgers University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00672269
Collaborator
(none)
25
1
26
1

Study Details

Study Description

Brief Summary

There is a high incidence among the first degree relatives of the carcinoid patients, indicating the involvement of genetic components in its initiation and pathogenesis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This proposed pilot study will conduct detailed interviews into the medical, environmental, and family histories and to collect blood specimen to obtain DNA. The Blood specimen and DNA will be processed by the Rutgers University Cell and DNA Repository (RUCDR) to rule out Familial Multiple Endocrine Neoplasia (MEN 1), and succinate dehydrogenase complex, subunit D (SDHD), gene inactivation thought to be associated with different types of carcinoid cancer.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    25 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    A Pilot Study to Investigate Germ-Line MEN1 and SDHD Gene Mutation in Familial Cases of Carcinoid Cancer
    Study Start Date :
    Apr 1, 2008
    Anticipated Primary Completion Date :
    Apr 1, 2009
    Anticipated Study Completion Date :
    Jun 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Families with carcinoid in multiple family members

    Outcome Measures

    Primary Outcome Measures

    1. Mutations in MEN1 and SDHD genes [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Over the age of 18 years

    2. More than one ,member of a family with a history of biopsy confirmed carcinoid tumor

    3. English speaking

    4. Mentally and emotionally capable of answering questions

    5. Willing and available for study participation

    6. At least one other family member with carcinoid tumor

    Exclusion Criteria:
    1. If you are under the age of 18 years,

    2. If you are unable to understand or unable to provide informed consent,

    3. If you have a psychological condition (i.e. depression, anxiety disorder, substance abuse, etc.) which might cause you significant problems in dealing with test results.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Busch Campus of Rutgers University, Human Genetics Institute Piscataway New Jersey United States 08854-8082

    Sponsors and Collaborators

    • Rutgers University

    Investigators

    • Principal Investigator: Nancy Gardner, PhD, Rutgers University
    • Principal Investigator: Changshun Shao, PhD, Rutgers University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00672269
    Other Study ID Numbers:
    • 08-451
    First Posted:
    May 6, 2008
    Last Update Posted:
    Feb 4, 2009
    Last Verified:
    Feb 1, 2009
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2009