Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors

Carcinoid Neuroendocrine Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00672269
• Other study ID #: 08-451
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2008
• Last updated: February 3, 2009
• Start date: April 2008
• Est. completion date: June 2010

Study information

• Verified date: February 2009
• Source: Rutgers University
• Contact: Nancy Gardner, PhD
• Phone: 813-731-0894
• Email: gardnern[@]rutgers.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoid Neuroendocrine Cancer
• Carcinoid Tumor

Locations

Country	Name	City	State
United States	Busch Campus of Rutgers University, Human Genetics Institute	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mutations in MEN1 and SDHD genes		1 year	No