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Diverse Ancestry Study in IBD

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06042387
Recruitment Status : Recruiting
First Posted : September 18, 2023
Last Update Posted : September 18, 2023
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mark Silverberg, Mount Sinai Hospital, Canada

Brief Summary:

Objective:

To use clinical, genetic and genome analysis to better understand and define the genetic and environmental factors that contribute to IBD in diverse ancestries:

African, African American, Black, Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or any other Black or Latin or indigenous ancestry.


Condition or disease Intervention/treatment
Ulcerative Colitis Healthy Crohn Disease Inflammatory Bowel Diseases Genetic: Blood or saliva sample collection

Detailed Description:

Background:

Inflammatory bowel disease (IBD) is a chronic, and often disabling, disorder of the intestines characterized by dysregulation of mucosal immune response. Recent data suggests that the incidence and prevalence rates among diverse populations may be increasing due to constantly changing environmental exposures. The goal of the study is to identify susceptible genes that contribute to the pathogenesis of IBD in individuals who self-identify as African, African American, Black, Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or any other Black or Latin or indigenous ancestry.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diverse Ancestry Study in Inflammatory Bowel Disease
Actual Study Start Date : May 1, 2022
Estimated Primary Completion Date : May 2027
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
IBD Subjects

Self-identify as:

Black, African, African American, Afro-Caribbean, Afro-Latino/a/x, or Hispanic/Latinx, Afro-Latino/a/x or any other Black or Latin or Indigenous ancestry

Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative colitis, IBD undetermined (IBD-U)) Any age

Genetic: Blood or saliva sample collection
Blood or saliva sample & clinical data collection

Controls

Self-identify as:

Black, African, African American, Afro-Caribbean, Afro-Latino/a/x, or Hispanic/Latinx, Afro-Latino/a/x or any other Black or Latin or Indigenous ancestry No personal history of IBD, no family history of IBD, no history of unexplained chronic diarrhea/blood in stool/anemia/abdominal pain/weight loss Any age

Genetic: Blood or saliva sample collection
Blood or saliva sample & clinical data collection




Primary Outcome Measures :
  1. Genetics studies in diverse ancestries [ Time Frame: 2022-2027 ]
    Whole Exome Sequencing (+/- other sequencing) is planned to assess genetic diversity in diverse populations.


Biospecimen Retention:   Samples With DNA

Participation involves:

One-time blood (preferred) or saliva sample Collection of clinical data



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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
IBD or Healthy controls who self-identify as African, African American, Black, Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or any other Black or Latin or indigenous ancestry
Criteria

Inclusion Criteria:

  • Subject must self-identify as African, African American, Black, Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or any other Black or Latin or indigenous ancestry
  • Subjects: diagnosed with Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis, IBD-undetermined)
  • Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative colitis, IBD undetermined (IBD-U))
  • Healthy controls: no personal history of IBD, no family history of IBD, no history of unexplained chronic diarrhea/blood in stool/anemia/abdominal pain/weight loss
  • Any age

Exclusion Criteria:

  • Doesn't self-identify as African, African American, Black, Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or any other Black or Latin or indigenous ancestry
  • Subjects with other gastrointestinal conditions not meeting the above IBD or Healthy Control criteria

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): NCT06042387


Contacts
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Contact: Joanne Stempak, MSc 4165864800 ext 8399 joanne.stempak@sinaihealth.ca
Contact: Jenny Lee, MKin 416-586-4800 ext 2318 jenny.lee2@sinaihealth.ca

Locations
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Canada, Ontario
Sinai Health System Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Joanne Stempak, MSc    4165864800 ext 8399    joanne.stempak@sinaihealth.ca   
Contact: Jenny Lee, MKin    4165864800 ext 2318    IBD.research@sinaihealth.ca   
Sponsors and Collaborators
Mount Sinai Hospital, Canada
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Mark Silverberg, MD PhD Sinai Health System
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Responsible Party: Mark Silverberg, Dr., Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT06042387    
Other Study ID Numbers: 02-0234-E
U01DK062423 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases