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Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS) (MAAIS)

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ClinicalTrials.gov Identifier: NCT01169194
Recruitment Status : Recruiting
First Posted : July 26, 2010
Last Update Posted : March 20, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor College of Medicine
Rutgers, The State University of New Jersey
University of Alabama at Birmingham
University of Chicago
University of Louisville
University of Maryland, College Park
University of North Carolina, Chapel Hill
University of Texas Southwestern Medical Center
Weill Medical College of Cornell University
Virginia Commonwealth University
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date June 16, 2010
First Posted Date July 26, 2010
Last Update Posted Date March 20, 2019
Actual Study Start Date June 2003
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01169194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS)
Official Title Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS)
Brief Summary The investigators are doing the research to discover genes that cause Inflammatory Bowel Disease (IBD) specifically in the African American population. African Americans with or without Crohn's disease or ulcerative colitis are eligible to join. If you agree to join the study, the investigators will ask for information about your health. The investigators will also ask you to give us a blood sample so that they may discover the genes that cause IBD. The blood sample may be collected at Johns Hopkins or any local facility convenient to you.
Detailed Description

This current protocol was established as part of an NIDDK initiative to further explore genetic factors associated with IBD. Specifically, the investigators are interested in identifying the genetic, environment and socio-economical components that contribute to the development of IBD in the African American population.

IBD is believed to be caused by a combination of environmental and genetic factors. Genetic data will be examined alongside potential environmental factors such as smoking, medications, environmental exposures, and some dietary factors. Since IBD is known to predominantly affect Western, industrialized areas of the world, the investigators will also inquire about participants' socioeconomic background in hopes of identifying any previously unknown factors in the AA population that may increase the risk of IBD. These potential environmental factors will be important in association analyses using covariates as these factors can obscure potential associations or interact with genetic factors and thus contribute to genetic associations. The investigators will also obtain information as to ancestry of parents and grandparents as to best match cases with unrelated controls of similar ancestry (e.g., Caribbean, recent European or recent African ancestry could cause genetic mismatch of a case and control). At the same time, the investigators will also collect similar information (smoking, medications, environmental exposures and dietary factors) from non-African Americans for the purpose of making direct comparisons for these parameters between the different racial groups to assess the contribution of non-genetic factors for susceptibility to the development of IBD.

This study calls for recruiting AA patients and ethnically matched controls (friend or spouse). These persons will provide us with a blood sample and with information requested on a questionnaire asking the following: clinical course and history of their IBD or their general health, smoking history, socioeconomic variables and specific dietary factors known in some populations to be related to IBD etiology. Access to medical records will be used to confirm diagnoses. The clinical characteristics of IBD obtained from medical records will be summarized in a phenotyping form using a standardized NIDDK IBDGC Phenotyping Operations Manual. Controls will be asked health history to identify potentially unrecognized IBD. DNA and other biospecimens will be purified from blood. Samples and data will also be shared with the NIDDK IBDGC for use in IBDGC research projects and will be processed and maintained at NIDDK repositories.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood and derivatives from blood, saliva
Sampling Method Non-Probability Sample
Study Population Individuals diagnosed with Inflammatory Bowel Disease
Condition Inflammatory Bowel Disease
Intervention Not Provided
Study Groups/Cohorts
  • Affected
    Patients with IBD
  • Unaffected
    Individuals who do not have IBD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July¬†23,¬†2010)
2400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. African Americans with a confirmed diagnosis of Inflammatory Bowel Disease (IBD)
  2. African Americans without a diagnosis of IBD and without a family history of IBD for comparison purposes

Exclusion Criteria: Patients whose IBD cannot be confirmed

Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Lisa Datta, MS 410-502-0040 ibd@jhu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01169194
Other Study ID Numbers NA_00041578
U01DK062431 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Baylor College of Medicine
  • Rutgers, The State University of New Jersey
  • University of Alabama at Birmingham
  • University of Chicago
  • University of Louisville
  • University of Maryland, College Park
  • University of North Carolina, Chapel Hill
  • University of Texas Southwestern Medical Center
  • Weill Medical College of Cornell University
  • Virginia Commonwealth University
Investigators
Study Director: Steven R Brant, MD Johns Hopkins University
Principal Investigator: Mark Lazarev, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2019