Collection of Specimens for Study of Inflammatory Bowel Disease

Procurement of Clinical Specimens for Immunologic or Genetic Studies in Inflammatory Bowel Diseases

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00086554

Enrollment

Unknown

Registered

2004-07-05

Start date

2004-07-01

Completion date

2010-01-08

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Keywords

Surgery, Intestinal Resection, Blood Sample

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

4 Years to No maximum

Healthy volunteers

Inclusion 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.

Countries

United States

Outcome results