Diverse Ancestry Study in IBD

Healthy Clinical Trial

Official title:

Diverse Ancestry Study in Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042387
• Other study ID #: 02-0234-E
• Secondary ID: U01DK062423
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: September 2027

Study information

• Verified date: September 2023
• Source: Mount Sinai Hospital, Canada
• Contact: Joanne Stempak, MSc
• Phone: 4165864800
• Email: joanne.stempak[@]sinaihealth.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Healthy
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Canada	Sinai Health System	Toronto	Ontario

Sponsors (2)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetics studies in diverse ancestries	Whole Exome Sequencing (+/- other sequencing) is planned to assess genetic diversity in diverse populations.	2022-2027