Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors

February 3, 2009 updated by: Rutgers University

A Pilot Study to Investigate Germ-Line MEN1 and SDHD Gene Mutation in Familial Cases of Carcinoid Cancer

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Piscataway, New Jersey, United States, 08854-8082
        • Recruiting
        • Busch Campus of Rutgers University, Human Genetics Institute
        • Contact:
        • Principal Investigator:
          • Changshun Shao, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals with carcinoid cancer that report to have a first-degree family member also with carcinoid tumor

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Families with carcinoid in multiple family members

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mutations in MEN1 and SDHD genes
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers University

Investigators

  • Principal Investigator: Changshun Shao, PhD, Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 5, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Estimate)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-451

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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