Inflammatory Bowel Disease Research Registry

The University of California Irvine Medical Center Inflammatory Bowel Disease Research Registry

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease

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.

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92503
      • UCI Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Performance of retrospective studies on inflammatory bowel disease to assess disease outcomes and response to therapy.	Records will be reviewed retrospectively from July 2013 and before.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	March 2008 through June 2013

Other Outcome Measures

Outcome Measure	Time Frame
Performance of studies to quantify disease phenotypes and treatment patterns.	March 2008 through June 2013

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Nimisha K Parekh, M.D., University of California, Irvine

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 12, 2007
• First Submitted That Met QC Criteria: December 13, 2007
• First Posted (Estimate): December 14, 2007

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: IBD Study
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: OCRT07006; 2007-5808