Inflammatory Bowel Disease Clinical Trial
Official title:
Telomere Repair Gene Mutations in Inflammatory Bowel Disease
NCT number | NCT00353639 |
Other study ID # | 060082 |
Secondary ID | 06-H-0082 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2006 |
Est. completion date | May 21, 2020 |
Verified date | May 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will evaluate and compare the genes of the telomere repair complex in healthy
control subjects, patients with blood diseases, and patients with inflammatory bowel disease
to identify what, if any, changes are associated specifically with inflammatory bowel
disease.
Patients between 2 and 80 years of age with ulcerative colitis or regional enteritis may be
eligible for this study. Participants are recruited from the practice of Dr. Stuart
Danovitch, Washington, D.C.
Researchers have established that minor differences in a specific set of genes called the
telomere repair complex are related to immune-mediated diseases of the bone marrow. NIH
researchers are now interested in whether inflammatory bowel disease and other autoimmune
diseases show a similar pattern of genetic differences.
Participants provide a cell sample for evaluation of the telomere repair complex. The sample
is collected via buccal swab, a gentle scraping of the inside of the cheek, and stored for
use in research.
Status | Completed |
Enrollment | 95 |
Est. completion date | May 21, 2020 |
Est. primary completion date | May 15, 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 80 Years |
Eligibility |
- INCLUSION CRITERIA: Diagnosis of ulcerative colitis or regional enteritis For adults: Ability to comprehend the investigational nature of the study and provide informed consent. Or For minors: Written informed consent from one parent or guardian and informed assent. The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend. Age greater than 2 but less or equal to 80 years old EXCLUSION CRITERIA: All subjects not fulfilling the inclusion criteria will be considered ineligible. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To identify if telomere repair complex gene mutations are abnormally prevalent among patients with IBO. | To identify if telomere repair complex gene mutations are abnormally prevalent among patients with IBO. | Ongoing | |
Secondary | To correlate telomere repair gene mutations in subjects with immune mediated disease stratified based on diagnosis as they relate to clinical course and response to therapy. | We aim to correlate telomere repair gene mutations in subjects with immune mediated disease stratified based on diagnosis with clinical course and response to therapy. | Ongoing | |
Secondary | To compare the telomere repair gene mutations of normal individuals (from large populations studies in the public domain) as well as to those of patients with known bone marrow failure | We aim to compare the telomere repair gene mutations of normal individuals with those of patients with known bone marrow failure | Ongoing |
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