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Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS): The Search for New Genes

This study is currently recruiting participants.
Verified July 2011 by Johns Hopkins University
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Crohn's and Colitis Foundation
The Johns Hopkins Meyerhoff Inflammatory Bowel Disease Center
Howard University
Washington Hospital Center
University of North Carolina
University of Florida
Henry Ford Hospital
Baylor College of Medicine
Columbia University
Weill Medical College of Cornell University
University of Maryland
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01169194
First received: June 16, 2010
Last updated: July 6, 2011
Last verified: July 2011
History of Changes
  Purpose

The investigators are doing the research to discover genes that cause Inflammatory Bowel Disease (IBD) specifically in the African American population. Who May Join This Study? Blacks / African Americans with or without Crohn's disease or ulcerative colitis.

If you agree to join the study, the investigators ask that you give us 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.


Condition
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Biospecimen Retention:   Samples With DNA

Blood samples from each participant will be sent to the NIDDK repository for DNA purification, sample distribution, establishment of cell lines. Serum samples will be sent to Fisher Bioservices Repository.

All additional samples will be processed and stored at Dr. Brant's Johns Hopkins IBD Genetics Laboratory with isolated lymphocytes and cell cultures made and stored at the Johns Hopkins Cell Center with use restricted to the PI (Dr. Brant).


Estimated Enrollment: 2400
Study Start Date: June 2003
Groups/Cohorts
Affected
Patients with IBD and their family members who have or do not have IBD.
Unaffected
Individuals who do not have IBD

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patient's of gastroenterology departments at medical centers.

Criteria

Inclusion Criteria:

  • Patients with IBD and their family members who have or do not have IBD.
  • People that do not have IBD are needed for comparison purposes.

Exclusion Criteria:

  • Patients whose IBD diagnosis can not be confirmed with medical records.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169194

Contacts
Contact: Patricia Ushry 1(888) 279-4194 ibd@jhu.edu
Contact: Denise Spears, BA (410) 502-5846 dspears1@jhmi.edu

Locations
United States, District of Columbia
Howard University Hospital Recruiting
Washington, District of Columbia, United States, 20060
Contact: Melvin Hall     202-865-4688     m_l_hall@howard.edu    
Principal Investigator: Duane Smoot, MD            
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Michelle Mendoza, MD, CCRC     202-877-6181     michelle.mendoza@medstar.net    
Sub-Investigator: Averell Sherker            
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Amy Gunnett, RN     352-265-0680 ext 40185     amy.gunnett@medicine.ufl.edu    
Principal Investigator: John Valentine, M. D.            
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21231
Contact: Patricia Ushry     888-279-4194     ibd@jhu.edu    
Contact: Denise Spears, BA     (410) 502-5846     dspears@jhu.edu    
Principal Investigator: Steven R Brant, M.D.            
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Nicole Samuels, CCRP     248-344-2358     qsamuel1@hfhs.org    
Contact: Sara Mukhashen, MSA     (313) 916-6049     smukhas1@hfhs.org    
Principal Investigator: Ann Silverman, M.D.            
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599-7032
Contact: Mikki Sandridge     919-843-3873     mikki_sandridge@med.unc.edu    
Contact: Dolly Walkup     (919) 843-8105     dolly_walkup@med.unc.edu    
Principal Investigator: Kim Isaacs, M.D., Phd            
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Crohn's and Colitis Foundation
The Johns Hopkins Meyerhoff Inflammatory Bowel Disease Center
Howard University
Washington Hospital Center
University of North Carolina
University of Florida
Henry Ford Hospital
Baylor College of Medicine
Columbia University
Weill Medical College of Cornell University
University of Maryland
Investigators
Principal Investigator: Steven R Brant, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Steven R. Brant, M.D., Johns Hopkins University-School of Medicine
ClinicalTrials.gov Identifier: NCT01169194     History of Changes
Other Study ID Numbers: 03-09-11-09, 1 UO1 DK62431
Study First Received: June 16, 2010
Last Updated: July 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
IBD
African American IBD
African American CD
African American UC
Black IBD
 Black CD
Black UC
African American Inflammatory Bowel Disease
African American Crohn's Disease
African American Ulcerative Colitis
Black Inflammatory Bowel Disease
Black Crohn's Disease
Black Ulcerative Colitis

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

ClinicalTrials.gov processed this record on May 22, 2013