An Investigation of Small Intestinal Carcinoid Carcinoma in Families

Carcinoid Carcinoma Clinical Trial

Official title:

An Investigation of Eight Reported Cases of Small Intestinal Carcinoid Carcinoma in Multiple Family Members

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00662168
• Other study ID #: 08-151
• Status: Recruiting
• Phase: N/A
• First received: April 17, 2008
• Last updated: April 17, 2008
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: April 2008
• Source: Rutgers University
• Contact: Nancy Gardner, PhD
• Phone: 973-991-1302
• Email: gardnern[@]rutgers.edu or nancymgardner[@]msn.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This proposed pilot study is to conduct detailed interviews into the medical, environmental, and family histories The second phase of this study project is to 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) and stored for a second phase of this pilot. The purpose is 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.

Description:

There have not been any studies published which specifically describe the medical, environmental, and genetic factors in carcinoid tumors cases that have carcinoid in family members. While rare, with an incidence of four per 100, 000, carcinoid represents the most frequent malignancy affecting the small intestine. Because nearly half (49%) of the cases of gastrointestinal carcinoid tumors have hepatic metastasis at diagnosis, identification of the risk factors associated with carcinoid has the potential to increase early diagnosis and cure. Carcinoid tumors are thought to occur spontaneously and not associated with an inherited genetic abnormality that would increase a family member's risk for developing carcinoid cancer. There is a known inherited genetic abnormality that is associated with bronchial carcinoid tumors but only less than 10%. Gastrointestinal carcinoid tumors are not thought to be associated with a inherited genetic abnormality. There have been several small studies that have examined gastrointestinal carcinoid in multiple family members. It remains uncertain if these cases of carcinoid in multiple family members are characteristic of a heritable or environmental etiology. Most carcinoid cancer is not inherited; however, less than 10% of neuroendocrine carcinoid cancer is thought to be due to a change (called a "mutation") in a gene inherited from a parent. There are several genes that are suspected to be associated with carcinoid cancer, two of interest in this study is the Multiple Endocrine Neoplasia Type1 (MEN1), and succinate dehydrogenase complex, subunit D (SDHD) genes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Over the age of 18 years

2. History of biopsy confirmed small intestinal carcinoid tumor

3. English speaking

4. Mentally and emotionally capable of answering questions

5. Willing and available for study participation

6. At least one first-degree family member with carcinoid tumor

Exclusion Criteria:

1. If you are under the age of 18 years,

2. If you have any mental or memory impairments

3. If you are unable to understand the information in the informed consent document.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoid Carcinoma
• Carcinoid Tumor
• Carcinoma

Locations

Country	Name	City	State
United States	Rutgers University College of Nursing	Newark	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	identification of carcinoid in multiple family members		lifetime history	No