Diverse Ancestry Study in IBD

Overview

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.

Full Title of Study: “Diverse Ancestry Study in Inflammatory Bowel Disease”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: May 2027

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.

Interventions

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

Arms, Groups and Cohorts

• 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
• 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

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Mount Sinai Hospital, Canada
• Collaborator
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Provider of Information About this Clinical Study
  • Principal Investigator: Mark Silverberg, Dr. – Mount Sinai Hospital, Canada
• Overall Official(s)
  • Mark Silverberg, MD PhD, Principal Investigator, Sinai Health System
• Overall Contact(s)
  • Joanne Stempak, MSc, 4165864800, joanne.stempak@sinaihealth.ca