Inflammatory Bowel Disease Research Registry

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574028
• Other study ID #: OCRT07006
• Secondary ID: 2007-5808
• Status: Completed
• Phase: N/A
• First received: December 12, 2007
• Last updated: December 9, 2014
• Start date: August 2007
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
United States	UCI Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Performance of studies to quantify disease phenotypes and treatment patterns.		March 2008 through June 2013	No
Primary	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.	No
Secondary	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	No