An Investigation of Small Intestinal Carcinoid Carcinoma in Families

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Rutgers University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rutgers University
ClinicalTrials.gov Identifier:
NCT00662168
First received: April 17, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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.


Condition
Carcinoid Carcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: An Investigation of Eight Reported Cases of Small Intestinal Carcinoid Carcinoma in Multiple Family Members

Resource links provided by NLM:


Further study details as provided by Rutgers University:

Primary Outcome Measures:
  • identification of carcinoid in multiple family members [ Time Frame: lifetime history ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: January 2008
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
observation
Individuals with a diagnosis of carcinoid carcinoma

Detailed 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.

  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 family member also with carcinoid tumor

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662168

Contacts
Contact: Nancy Gardner, PhD 973-991-1302 gardnern@rutgers.edu or nancymgardner@msn.com

Locations
United States, New Jersey
Rutgers University College of Nursing Recruiting
Newark, New Jersey, United States, 07102
Contact: Nancy Gardner, PhD    973-991-1302    gardnern@rutgers.edu   
Principal Investigator: Nancy Gardner, PhD         
Sponsors and Collaborators
Rutgers University
Investigators
Principal Investigator: Nancy Gardner, PhD Rutgers University
  More Information

No publications provided

Responsible Party: Nancy Gardner, PhD. Assistant Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT00662168     History of Changes
Other Study ID Numbers: 08-151
Study First Received: April 17, 2008
Last Updated: April 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers University:
carcinoid
familial
Collect and describe information about the medical and environmental factors associated with each cases of carcinoid carcinoma
Develop a genogram representing the family cancer history of cases of Carcinoid.

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

ClinicalTrials.gov processed this record on July 28, 2014