Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00672269
Recruitment Status : Unknown
Verified February 2009 by Rutgers University.
Recruitment status was:  Recruiting
First Posted : May 6, 2008
Last Update Posted : February 4, 2009
Information provided by:
Rutgers University

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
Carcinoid Neuroendocrine Cancer

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
Estimated 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 : April 2008
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : June 2010

Families with carcinoid in multiple family members

Primary Outcome Measures :
  1. Mutations in MEN1 and SDHD genes [ Time Frame: 1 year ]

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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00672269

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

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   
Contact: Nancy Gardner, PhD    973-991-1302   
Principal Investigator: Changshun Shao, PhD         
Principal Investigator: Nancy Gardner, PhD         
Sponsors and Collaborators
Rutgers University
Principal Investigator: Nancy Gardner, PhD Rutgers University
Principal Investigator: Changshun Shao, PhD Rutgers University

Responsible Party: Nancy Gardner PhD Principal Investigator, Rutgers University Identifier: NCT00672269     History of Changes
Other Study ID Numbers: 08-451
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by Rutgers University:
family members

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