RECRUITING

Natural History of Familial Carcinoid Tumor

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 detection by performing surveillance on those at risk but without disease and to identify the gene(s) that may cause the tumors. Familial carcinoid tumors usually originate in hormone-producing cells that line the small intestine or other cells of the digestive tract. The tumors are slow-growing and usually take many years before they cause symptoms. It is known that these tumors occur more often in some families and are then passed from one generation to the next by inherited genes. Members of families, including all siblings and offspring in which two or more immediate blood relatives have had small bowel carcinoid tumors are eligible for this study. In some cases unaffected spouses of family members diagnosed with carcinoid cancer are also requested to participate by donating a sample of blood only. Participants undergo a medical evaluation every 3 years during a 3- to 5-day hospital stay at the NIH Clinical Center. All participants have a personal and family medical history obtained and undergo a physical examination, blood and urine tests. People who already have a small bowel carcinoid tumor or are at risk of developing a carcinoid tumor have some or all of the following procedures to determine the presence of carcinoid tumor and its (omit next two words- location or) spread to other areas of the body: * Video Capsule Endoscopy: Visualization of the gastrointestinal tract by ingesting a disposable, "vitamin-pill sized" video capsule that has its own camera and light source. * CT of the chest abdomen and pelvis with oral and IV contrast : X-ray examination of the chest, abdominal and pelvis organs. * 18 FDOPA Positron emission tomography (PET) with CT for localization: Nuclear imaging scan to look at tumor activity. * MRI Liver with contrast - to determine if disease has spread to liver * Gallium 68 PET/CT-limited to individuals that have residual tumor. * Clinical and research blood work Should mid gut carcinoid tumors be found every participant will be assisted in determine what the best course of treatment will be for them. ...

Official Title

Natural History of Familial Carcinoid Tumor

Quick Facts

Study Start:2008-08-25
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00646022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female subjects \>= 18 years of age
  2. * Have a diagnosis of small intestinal carcinoid tumor
  3. * 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
  4. * Male and female subjects \>= 18 years of age
  5. * Has multiple synchronous primary small intestinal tumors
  6. * Male and female subjects \>=18 years of age
  7. * Does not have a diagnosis of carcinoid tumor
  8. * Has one of the following:
  9. * 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
  10. * has at least one blood relative with multiple, synchronous primary small bowel tumors
  11. * Male and female subjects \>= 18 years of age
  12. * Not biologically related to the participating family but has offspring who is/are blood relative(s) of a participating subject.
  1. 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
  2. 2. Any condition which, in the opinion of the investigator, would make it unsafe to participate or would prohibit completion of the protocol.
  3. 3. Inability to provide informed consent (Arm 1 only)
  4. 4. Pregnant or breastfeeding (Arm 1 only)

Contacts and Locations

Study Contact

Joanne Forbes, C.R.N.P.
CONTACT
(301) 443-9557
forbesjo@mail.nih.gov
Stephen A Wank, M.D.
CONTACT
(301) 496-4202
stevew@mail.nih.gov

Principal Investigator

Stephen A Wank, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Stephen A Wank, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2008-08-25
Study Completion DateN/A

Study Record Updates

Study Start Date2008-08-25
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Neuroendocrine
  • PET
  • Gastrointestinal
  • Serotonin
  • Natural History
  • Carcinoid Tumor
  • Gastrointestinal Carcinoid Tumor
  • Familial Cancer Tumor

Additional Relevant MeSH Terms

  • Carcinoid