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Collection of Specimens for Study of Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Diseases

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Inflammatory Bowel Diseases focused on measuring Surgery, Intestinal Resection, Blood Sample

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA FOR SUBJECTS WITH INFLAMMATORY BOWEL DISEASE: Presence of idiopathic inflammatory bowel disease as established by prior endoscopic, histologic, and/or radiographic findings. 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: Absence of idiopathic inflammatory bowel disease as established by tests that exclude these diagnoses. Ability to give consent and agree to sample storage. EXCLUSION CRITERIA FOR SUBJECTS WITHOUT INFLAMMATORY BOWEL DISEASE: 1. Less than 18 years of age.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 2, 2004
Last Updated
June 30, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00086554
Brief Title
Collection of Specimens for Study of Inflammatory Bowel Disease
Official Title
Procurement of Clinical Specimens for Immunologic or Genetic Studies in Inflammatory Bowel Diseases
Study Type
Observational

2. Study Status

Record Verification Date
January 8, 2010
Overall Recruitment Status
Completed
Study Start Date
July 1, 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 8, 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Surgery, Intestinal Resection, Blood Sample

7. Study Design

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA FOR SUBJECTS WITH INFLAMMATORY BOWEL DISEASE: Presence of idiopathic inflammatory bowel disease as established by prior endoscopic, histologic, and/or radiographic findings. 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: Absence of idiopathic inflammatory bowel disease as established by tests that exclude these diagnoses. Ability to give consent and agree to sample storage. EXCLUSION CRITERIA FOR SUBJECTS WITHOUT INFLAMMATORY BOWEL DISEASE: 1. Less than 18 years of age.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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Collection of Specimens for Study of Inflammatory Bowel Disease

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