Inflammatory Bowel Disease Research Registry

NCT ID: NCT00574028

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Inflammatory Bowel Disease

Keywords

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IBD Study

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Nimisha Parekh

Associate Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nimisha K Parekh, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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UCI Medical Center

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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2007-5808

Identifier Type: -

Identifier Source: secondary_id

OCRT07006

Identifier Type: -

Identifier Source: org_study_id