An Investigation of Small Intestinal Carcinoid Carcinoma in Families

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: NCT00662168
Recruitment Status : Unknown
Verified April 2008 by Rutgers University.
Recruitment status was:  Recruiting
First Posted : April 21, 2008
Last Update Posted : April 21, 2008
Information provided by:
Rutgers University

Brief 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.

Condition or disease
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.

Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: An Investigation of Eight Reported Cases of Small Intestinal Carcinoid Carcinoma in Multiple Family Members
Study Start Date : January 2008
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : November 2008

Individuals with a diagnosis of carcinoid carcinoma

Primary Outcome Measures :
  1. identification of carcinoid in multiple family members [ Time Frame: lifetime history ]

Information from the National Library of Medicine

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

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.

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): NCT00662168

Contact: Nancy Gardner, PhD 973-991-1302 or

United States, New Jersey
Rutgers University College of Nursing Recruiting
Newark, New Jersey, United States, 07102
Contact: Nancy Gardner, PhD    973-991-1302   
Principal Investigator: Nancy Gardner, PhD         
Sponsors and Collaborators
Rutgers University
Principal Investigator: Nancy Gardner, PhD Rutgers University

Responsible Party: Nancy Gardner, PhD. Assistant Professor, Rutgers University Identifier: NCT00662168     History of Changes
Other Study ID Numbers: 08-151
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: April 21, 2008
Last Verified: April 2008

Keywords provided by Rutgers University:
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue