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Phenotypic Characteristics of Inflammatory Bowel Disease in Southeast Asian Population - A Multi-centered US Study

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573846
First Posted: December 14, 2007
Last Update Posted: January 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Kentucky
University of Texas Southwestern Medical Center
Texas Health Resources
Mayo Clinic
Jefferson Medical College of Thomas Jefferson University
Information provided by (Responsible Party):
Nimisha Parekh, University of California, Irvine
  Purpose
This is a retrospective, case control study of inflammatory bowel disease. This study will analyze the phenotypic characteristics of inflammatory bowel disease in the Southeast Asian population and will help describe clinical characteristics and serologic profiles in Southeast Asians with inflammatory bowel disease, comparing the phenotype differences to historical Caucasian controls. The data from this study will help identify the phenotype characteristics of different ethnic groups and study the epidemiological patterns of the disease.

Condition
Inflammatory Bowel Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Phenotypic Characteristics of Inflammatory Bowel Disease in Southeast Asian Population - A Multi-centered US Study

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

Primary Outcome Measures:
  • Phenotypic characteristics of inflammatory bowel disease in southeast asian population [ Time Frame: 12 months ]
    Retrospective chart review


Enrollment: 0
Study Start Date: July 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

This study is a retrospective, case control study of inflammatory bowel disease characteristics in patients with origins from the Indian sub-continent. Patients will be selected from the IBD registry maintained at respective institutions. Subjects from the Indian sub-continent will be identified using their country of birth, parents' ethnicity, number of years since leaving the country of birth, and number of years residing in the United States.

Using both electronic and paper databases, demographic information regarding age, gender, body mass index, smoking history, dietary habits; medical history such as type of IBD, IBD symptoms, location and behavior, medication use (past and current), history of other autoimmune disorders; surgical history (IBD and non-IBD related); laboratory indices such as IBD serology, Thiopurinemethyltransferase (TPMT), and infliximab levels will be collected.

Demographics will be compared between groups using descriptive statistics. Using univariate analysis, variables that are significantly different will be identified. Conditional logistic regression will then be performed to identify those clinical variables that are statistically significant.

The study duration will be one year from IRB approval.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected from the IBD registry maintained at respective institutions. Subjects from the Indian sub-continent will be identified using their country of birth, parents' ethnicity, number of years since leaving the country of birth, and number of years residing in the United States.
Criteria

Inclusion Criteria:

  • Patients with origins from the Indian sub-continent
  • Patients will be selected from the IBD registry maintained at respective institutions.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573846


Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
University of Kentucky
University of Texas Southwestern Medical Center
Texas Health Resources
Mayo Clinic
Jefferson Medical College of Thomas Jefferson University
Investigators
Principal Investigator: Nimisha K Parekh, M.D. University of California, Irvine
  More Information

Responsible Party: Nimisha Parekh, Assistant Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00573846     History of Changes
Other Study ID Numbers: OCRT07005
2007-5807
First Submitted: December 12, 2007
First Posted: December 14, 2007
Last Update Posted: January 28, 2015
Last Verified: January 2015

Keywords provided by Nimisha Parekh, University of California, Irvine:
IBD

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