Collection of Specimens for Study of Inflammatory Bowel Disease
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 4 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2004 |
| End Date: | January 2010 |
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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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