Bowel Disease Research Registry
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Purpose
The objective and aims of this study is to develop The University of California Irvine Medical Center Inflammatory Bowel Disease Research Registry for the purpose of:
- Performance of retrospective studies on inflammatory bowel disease to assess disease outcomes and response to therapy.
- Obtaining permission from the Research Registry participants to be contacted by members of The University of California Irvine Medical Center Inflammatory Bowel Disease Research Center to identify patients that may be eligible for participation in future research studies.
- Performance of studies to quantify disease phenotypes and treatment patterns.
| Condition |
|---|
|
Inflammatory Bowel Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | The University of California Irvine Medical Center Inflammatory Bowel Disease Research Registry |
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2013 |
PURPOSE:
The goal of The University of California Irvine Medical Center Inflammatory Bowel Disease Research Registry is to study IBD characteristics, response to therapy, and disease outcomes. The information will also serve to identify patients for future research studies.
Objective and Specific Aims
The objective is to develop The University of California Irvine Medical Center Inflammatory Bowel Disease Research Registry for the purpose of:
- Performance of retrospective studies on inflammatory bowel disease to assess disease outcomes and response to therapy.
- Obtaining permission from the Research Registry participants to be contacted by members of The University of California Irvine Medical Center Inflammatory Bowel Disease Research Center to identify patients that may be eligible for participation in future research studies.
- Performance of studies to quantify disease phenotypes and treatment patterns.
STUDY DESIGN:
Participation in The University of California Irvine Medical Center Inflammatory Bowel Disease Research Registry is limited to placement of a subjects' identifiable medical information related to inflammatory bowel disease in a database and the use of this information for retrospective research studies of inflammatory bowel disease.
Patients who present or develop inflammatory bowel disease at The University of California Irvine Medical Center will be asked to participate in the Research Registry. Patients must provide written, informed consent to allow past, current and future identifiable medical records related to gastrointestinal hemorrhage to be placed in the study's registry. The medical record information that will be used for the Research Registry will be directly related to inflammatory bowel disease. However, since concurrent medical conditions and treatments, not directly related to inflammatory bowel disease may impact inflammatory bowel disease it is likely that all of the past, current and future identifiable medical record information will be placed in the Research Registry.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The characteristics of the proposed subject population include:
- Subjects, male or female, 18 years of age or older
- Patients receiving or seeking medical care at UCI Medical Center diagnosed with IBD.
- Subjects who are unable to read or speak English
- Adults who are competent to give informed consent
- Subjects of any race or ethnicity
Inclusion Criteria:
- Patients receiving or seeking care at UCI Medical Center diagnosed with IBD
Exclusion Criteria:
- Subjects under the age of 18
- Prisoner of the state
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Nimisha K. Parekh, M.D., University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00574028 History of Changes |
| Other Study ID Numbers: | OCRT07006, 2007-5808 |
| Study First Received: | December 12, 2007 |
| Last Updated: | December 13, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
IBD Study |
Additional relevant MeSH terms:
|
Inflammatory Bowel Diseases Intestinal Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013