Status:
RECRUITING
Natural History of Familial Carcinoid Tumor
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Carcinoid
Eligibility:
All Genders
18-100 years
Brief Summary
This study will evaluate members in families with a history of small bowel carcinoid cancer to study the natural history of those family members that have the disease, determine ways to improve early ...
Detailed Description
Study Description: This study is designed as a prospective evaluation for diagnostic screening, genotyping and natural history of participants belonging to kindreds with familial carcinoid tumor. Ob...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- There are four types of participants who will be included in this protocol as outlined below.
- In order to be eligible to participate in this study, an individual must meet all of the following criteria for their group:
- Group 1 (Arm 1 or Arm 2)
- Male and female subjects \>= 18 years of age
- Have a diagnosis of small intestinal carcinoid tumor
- Have at least one blood relation with a diagnosis of either small intestinal, pulmonary, kidney or gastropancreatic neuroendocrine tumor or metastatic neuroendocrine tumor of unknown primary
- Group 2 (Arm 1 or Arm 2)
- Male and female subjects \>= 18 years of age
- Has multiple synchronous primary small intestinal tumors
- Group 3 (Arm 1 or Arm 2)
- Male and female subjects \>=18 years of age
- Does not have a diagnosis of carcinoid tumor
- Has one of the following:
- at least two blood relatives with any combination of diagnoses of small intestinal carcinoid tumor, a pulmonary, kidney, gastropancreatic neuroendocrine tumor or metastatic neuroendocrine tumor of unknown primary OR
- has at least one blood relative with multiple, synchronous primary small bowel tumors
- Group 4 (Arm 2 only)
- Male and female subjects \>= 18 years of age
- Not biologically related to the participating family but has offspring who is/are blood relative(s) of a participating subject.
- EXCLUSION CRITERIA:
- An individual who meets any of the following criteria will be excluded from participation in this
- study:
- Members of families with multiple endocrine neoplasia (MEN) I, MEN II or other familial tumor syndromes such as Von Hippel Lindau Syndrome and Neurofibromatosis type I and type II for which there is a known genetic predisposition to non-carcinoid tumors as well as
- carcinoid tumors will be excluded from the study.
- Any condition which, in the opinion of the investigator, would make it unsafe to participate or would prohibit completion of the protocol.
- Inability to provide informed consent (Arm 1 only)
- Pregnant or breastfeeding (Arm 1 only)
Exclusion
Key Trial Info
Start Date :
August 25 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT00646022
Start Date
August 25 2008
Last Update
January 9 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892