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

July 2, 2004
January 9, 2010
July 2004
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00086554 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collection of Specimens for Study of Inflammatory Bowel Disease
Procurement of Clinical Specimens for Immunologic or Genetic Studies in Inflammatory Bowel Diseases

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.

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.

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Inflammatory Bowel Diseases
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
January 2010
Not Provided
  • 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.

Both
4 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00086554
040231, 04-I-0231
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP