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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by University of California, Irvine.
Recruitment status was  Active, not recruiting
Sponsor:
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:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00573846
First received: December 12, 2007
Last updated: December 13, 2007
Last verified: December 2007

December 12, 2007
December 13, 2007
July 2007
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Complete list of historical versions of study NCT00573846 on ClinicalTrials.gov Archive Site
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Phenotypic Characteristics of Inflammatory Bowel Disease in Southeast Asian Population - A Multi-Centered US Study
Phenotypic Characteristics of Inflammatory Bowel Disease in Southeast Asian Population - A Multi-Centered US Study

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample

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.

Inflammatory Bowel Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
July 2008
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Inclusion Criteria:

  • Patients with origins from the Indian sub-continent
  • Patients will be selected from the IBD registry maintained at respective institutions.
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00573846
OCRT07005, 2007-5807
No
Nimisha K. Parekh, M.D., University of California, Irvine
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
Principal Investigator: Nimisha K Parekh, M.D. University of California, Irvine
University of California, Irvine
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP