Phenotypic Characteristics of Inflammatory Bowel Disease in Southeast Asian Population - A Multi-Centered US Study
Recruitment status was Active, not recruiting
|First Received Date ICMJE||December 12, 2007|
|Last Updated Date||December 13, 2007|
|Start Date ICMJE||July 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00573846 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Phenotypic Characteristics of Inflammatory Bowel Disease in Southeast Asian Population - A Multi-Centered US Study|
|Official Title ICMJE||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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Time Perspective: Retrospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||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.
|Condition ICMJE||Inflammatory Bowel Diseases|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||20|
|Estimated Completion Date||July 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00573846|
|Other Study ID Numbers ICMJE||OCRT07005, 2007-5807|
|Has Data Monitoring Committee||No|
|Responsible Party||Nimisha K. Parekh, M.D., University of California, Irvine|
|Study Sponsor ICMJE||University of California, Irvine|
|Information Provided By||University of California, Irvine|
|Verification Date||December 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP