Genome Analysis Across Populations in Inflammatory Bowel Disease

NCT06042387 | Recruiting

• 2 other identifiers: 02-0234-EU01DK062423
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To use clinical, genetic and genome analysis to better understand and define the genetic and environmental factors that contribute to IBD within affected populations.

Conditions

Ulcerative Colitis; Healthy; Crohn Disease; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Genomics studies across populations

  Whole Exome Sequencing (+/- other sequencing) is planned

  2022-2027

Study Arms (2)

IBD Subjects

Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative colitis, IBD undetermined (IBD-U)) Any age Willing to provide blood or saliva sample

Genetic: Blood or saliva sample collection

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 Willing to provide blood or saliva sample

Genetic: Blood or saliva sample collection

Interventions

Blood or saliva sample collection GENETIC

Blood or saliva sample \& clinical data collection

Controls; IBD Subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IBD or Healthy controls (non-IBD)

You may qualify if:

• 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

You may not qualify if:

• \- Subjects with other gastrointestinal conditions not meeting the above IBD or Healthy Control criteria

Sponsors & Collaborators

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

Study Sites (1)

Sinai Health System

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mark Silverberg, MD PhD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne Stempak, MSc

CONTACT

4165864800; joanne.stempak@sinaihealth.ca

Jenny Lee, MKin

CONTACT

416-586-4800; jenny.lee2@sinaihealth.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: September 18, 2023
• Study Start: May 1, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CA (1)