Diverse Ancestry Study in IBD

Sponsor
Mount Sinai Hospital, Canada (Other)
Overall Status
Recruiting
CT.gov ID
NCT06042387
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
150
1
64
2.3

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Primary Completion Date :
May 1, 2027
Anticipated Study Completion Date :
Sep 1, 2027

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Genetics studies in diverse ancestries [2022-2027]

    Whole Exome Sequencing (+/- other sequencing) is planned to assess genetic diversity in diverse populations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sinai Health System Toronto Ontario Canada M5G 1X5

Sponsors and Collaborators

  • Mount Sinai Hospital, Canada
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Mark Silverberg, MD PhD, Sinai Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark Silverberg, Dr., Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT06042387
Other Study ID Numbers:
  • 02-0234-E
  • U01DK062423
First Posted:
Sep 18, 2023
Last Update Posted:
Sep 18, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 18, 2023