Evaluating the natural history of familial carcinoid tumors
Natural History of Familial Carcinoid Tumor
This study looks at families with a history of small bowel carcinoid tumors to see how the disease develops over time and to find better ways to detect it early in those at risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00646022 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on families with a history of small bowel carcinoid tumors to understand the natural progression of the disease. It aims to improve early detection methods for at-risk individuals who do not yet have the disease and to identify potential genetic factors contributing to tumor development. Participants will undergo various diagnostic screenings, including imaging and biochemical tests, and provide samples for genetic analysis. The study will also evaluate the effectiveness of different diagnostic modalities in detecting carcinoid tumors.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older with a diagnosis of small intestinal carcinoid tumors or those with a family history of neuroendocrine tumors.
Not a fit: Patients without a family history of carcinoid tumors or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of familial carcinoid tumors, improving patient outcomes.
How similar studies have performed: While there have been studies on carcinoid tumors, this specific approach focusing on familial patterns and genetic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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: 1. 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. 2. Any condition which, in the opinion of the investigator, would make it unsafe to participate or would prohibit completion of the protocol. 3. Inability to provide informed consent (Arm 1 only) 4. Pregnant or breastfeeding (Arm 1 only)
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Stephen A Wank, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Joanne Forbes, C.R.N.P.
- Email: forbesjo@mail.nih.gov
- Phone: (301) 443-9557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.