An Investigation of Small Intestinal Carcinoid Carcinoma in Families

Sponsor
Rutgers University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00662168
Collaborator
(none)
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Study Details

Study Description

Brief Summary

This proposed pilot study is to conduct detailed interviews into the medical, environmental, and family histories The second phase of this study project is to 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) and stored for a second phase of this pilot. The purpose is 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    There have not been any studies published which specifically describe the medical, environmental, and genetic factors in carcinoid tumors cases that have carcinoid in family members. While rare, with an incidence of four per 100, 000, carcinoid represents the most frequent malignancy affecting the small intestine. Because nearly half (49%) of the cases of gastrointestinal carcinoid tumors have hepatic metastasis at diagnosis, identification of the risk factors associated with carcinoid has the potential to increase early diagnosis and cure. Carcinoid tumors are thought to occur spontaneously and not associated with an inherited genetic abnormality that would increase a family member's risk for developing carcinoid cancer. There is a known inherited genetic abnormality that is associated with bronchial carcinoid tumors but only less than 10%. Gastrointestinal carcinoid tumors are not thought to be associated with a inherited genetic abnormality. There have been several small studies that have examined gastrointestinal carcinoid in multiple family members. It remains uncertain if these cases of carcinoid in multiple family members are characteristic of a heritable or environmental etiology. Most carcinoid cancer is not inherited; however, less than 10% of neuroendocrine carcinoid cancer is thought to be due to a change (called a "mutation") in a gene inherited from a parent. There are several genes that are suspected to be associated with carcinoid cancer, two of interest in this study is the Multiple Endocrine Neoplasia Type1 (MEN1), and succinate dehydrogenase complex, subunit D (SDHD) genes.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    8 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    An Investigation of Eight Reported Cases of Small Intestinal Carcinoid Carcinoma in Multiple Family Members
    Study Start Date :
    Jan 1, 2008
    Anticipated Primary Completion Date :
    Nov 1, 2008
    Anticipated Study Completion Date :
    Nov 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    observation

    Individuals with a diagnosis of carcinoid carcinoma

    Outcome Measures

    Primary Outcome Measures

    1. identification of carcinoid in multiple family members [lifetime history]

    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. History of biopsy confirmed small intestinal carcinoid tumor

    3. English speaking

    4. Mentally and emotionally capable of answering questions

    5. Willing and available for study participation

    6. At least one first-degree family member with carcinoid tumor

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

    2. If you have any mental or memory impairments

    3. If you are unable to understand the information in the informed consent document.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rutgers University College of Nursing Newark New Jersey United States 07102

    Sponsors and Collaborators

    • Rutgers University

    Investigators

    • Principal Investigator: Nancy Gardner, PhD, Rutgers University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00662168
    Other Study ID Numbers:
    • 08-151
    First Posted:
    Apr 21, 2008
    Last Update Posted:
    Apr 21, 2008
    Last Verified:
    Apr 1, 2008

    Study Results

    No Results Posted as of Apr 21, 2008