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Bowel Disease Research Registry
This study is ongoing, but not recruiting participants.
First Received: December 12, 2007   Last Updated: December 13, 2007   History of Changes
Sponsored by: University of California, Irvine
Information provided by: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00574028
  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:

  1. Performance of retrospective studies on inflammatory bowel disease to assess disease outcomes and response to therapy.
  2. 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.
  3. Performance of studies to quantify disease phenotypes and treatment patterns.

Condition
Inflammatory Bowel Disease

Genetics Home Reference related topics: Crohn disease
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: The University of California Irvine Medical Center Inflammatory Bowel Disease Research Registry

Further study details as provided by University of California, Irvine:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 500
Study Start Date: August 2007
Estimated Study Completion Date: August 2013
Detailed Description:

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:

  1. Performance of retrospective studies on inflammatory bowel disease to assess disease outcomes and response to therapy.
  2. 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.
  3. 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
Study Population

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574028

Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Nimisha K Parekh, M.D. University of California, Irvine
  More Information

No publications provided

Responsible Party: University of California, Irvine ( Nimisha K. Parekh, M.D. )
Study ID Numbers: OCRT07006, 2007-5808
Study First Received: December 12, 2007
Last Updated: December 13, 2007
ClinicalTrials.gov Identifier: NCT00574028     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
IBD Study

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009