Collection of Specimens for Study of Inflammatory Bowel Disease

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00086554
First received: July 2, 2004
Last updated: January 9, 2010
Last verified: January 2010
  Purpose

This study will collect tissue specimens to be used for research on inflammatory bowel disease. The tissues will be used to explore why people get inflammatory bowel disease and to try to develop new treatments based on the study results. Tissue from patients with IBD will be compared with that from patients who do not have the disease

Patients who undergo bowel surgery for inflammatory bowel disease (IBD) or another bowel disorder may be eligible for this study. Patients with IBD must be at least 4 years of age; those with another disorder must be 18 years of age or older.

Participants undergo bowel surgery for their disease. Some of the intestinal tissue removed during the surgery that is not needed for medical care, such as for pathological examination, is provided to researchers for study under this protocol. In addition, patients with IBD provide a blood sample for genetic testing. Several genetic variations, or mutations, may increase the risk of developing IBD; blood samples from patients may help identify these variations.


Condition
Inflammatory Bowel Diseases

Study Type: Observational
Official Title: Procurement of Clinical Specimens for Immunologic or Genetic Studies in Inflammatory Bowel Diseases

Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date: July 2004
Estimated Study Completion Date: January 2010
Detailed Description:

Our ongoing natural history studies of the etiology and immune abnormalities of the group of diseases known collectively as the inflammatory bowel diseases require access to clinical samples of intestinal tissue as well as blood samples for genotyping. This protocol provides a mechanism for procurement of intestinal samples obtained at the time of medically-indicated surgical procedures from patients with IBD or some other non-IBD diagnosis (to act as a control group). In addition it allows for the procurement of blood for DNA preparation as more IBD susceptibility genes are discovered and we further our work on association of genetic polymorphisms/mutations with the phenotype and immune abnormalities observed in our IBD patients.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA FOR SUBJECTS WITH INFLAMMATORY BOWEL DISEASE:

    1. Presence of idiopathic inflammatory bowel disease as established by prior endoscopic, histologic, and/or radiographic findings.
    2. Ability to give consent or have legally authorized person give consent and agree to sample storage.

EXCLUSION CRITERIA FOR SUBJECTS WITH INFLAMMATORY BOWEL DISEASE:

1. Less than 4 years old.

INCLUSION CRITERIA FOR SUBJECTS WITHOUT INFLAMMATORY BOWEL DISEASE:

  1. Absence of idiopathic inflammatory bowel disease as established by tests that exclude these diagnoses.
  2. Ability to give consent and agree to sample storage.

EXCLUSION CRITERIA FOR SUBJECTS WITHOUT INFLAMMATORY BOWEL DISEASE:

1. Less than 18 years of age.

  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: NCT00086554

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00086554     History of Changes
Other Study ID Numbers: 040231, 04-I-0231
Study First Received: July 2, 2004
Last Updated: January 9, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Surgery
Intestinal Resection
Blood Sample

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014