Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors - Full Text View

Sponsor:	Rutgers University
Information provided by:	Rutgers University
ClinicalTrials.gov Identifier:	NCT00672269

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:	Case Control, 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:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Carcinoid Tumors

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

Biospecimen Description:

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:

Over the age of 18 years
More than one ,member of a family with a history of biopsy confirmed carcinoid tumor
English speaking
Mentally and emotionally capable of answering questions
Willing and available for study participation
At least one other family member with carcinoid tumor

Exclusion Criteria:

If you are under the age of 18 years,
If you are unable to understand or unable to provide informed consent,
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:	Rutgers University ( Nancy Gardner PhD Principal Investigator )
Study ID Numbers:	08-451
Study First Received:	May 2, 2008
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00672269 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Rutgers University:

carcinoid
family members
familial
tumors
cancer

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue

Carcinoid Tumor
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma
Neuroendocrine Tumors

ClinicalTrials.gov processed this record on February 08, 2010