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Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Rutgers University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rutgers University
ClinicalTrials.gov Identifier:
NCT00672269
First received: May 2, 2008
Last updated: February 3, 2009
Last verified: February 2009
History of Changes
  Purpose

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
Carcinoid Neuroendocrine Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rutgers University:

Primary Outcome Measures:
  • Mutations in MEN1 and SDHD genes [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood: a small sample of 2 tubes (2 - 4 teaspoons, or 20 ml). One tube will be used to prepare the DNA (your genetic material) for the test. The other would be used for further gene evaluation. The DNA will be stored with Rutgers University Cell and DNA Repository (RUCDR).


Estimated Enrollment: 25
Study Start Date: April 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Families with carcinoid in multiple family members

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672269

Contacts
Contact: Nancy Gardner, PhD 813-731-0894 gardnern@rutgers.edu
Contact: Changshun Shao, PhD Shao@Biology.Rutgers.Edu

Locations
United States, New Jersey
Busch Campus of Rutgers University, Human Genetics Institute Recruiting
Piscataway, New Jersey, United States, 08854-8082
Contact: Changshun Shao, PhD     732-445-5406     shao@biology.rutgers.edu    
Contact: Nancy Gardner, PhD     973-991-1302     gardnern@rutgers.edu    
Principal Investigator: Changshun Shao, PhD            
Principal Investigator: Nancy Gardner, PhD            
Sponsors and Collaborators
Rutgers University
Investigators
Principal Investigator: Nancy Gardner, PhD Rutgers University
Principal Investigator: Changshun Shao, PhD Rutgers University
  More Information

No publications provided

Responsible Party: Nancy Gardner PhD Principal Investigator, Rutgers University
ClinicalTrials.gov Identifier: NCT00672269     History of Changes
Other Study ID Numbers: 08-451
Study First Received: May 2, 2008
Last Updated: February 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers University:
carcinoid
family members
familial
tumors
cancer

Additional relevant MeSH terms:
Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 22, 2013