Genome Analysis Across Populations in Inflammatory Bowel Disease

NCT ID: NCT06042387

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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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 all 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 affected individuals.

Conditions

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Ulcerative Colitis Healthy Crohn Disease Inflammatory Bowel Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Blood or saliva sample collection

Intervention Type GENETIC

Blood or saliva sample \& clinical data 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

Blood or saliva sample collection

Intervention Type GENETIC

Blood or saliva sample \& clinical data collection

Interventions

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Blood or saliva sample collection

Blood or saliva sample \& clinical data collection

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* 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

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

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role lead

Responsible Party

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Mark Silverberg

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Silverberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sinai Health System

Locations

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Sinai Health System

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Joanne Stempak, MSc

Role: CONTACT

4165864800 ext. 8399

Jenny Lee, MKin

Role: CONTACT

416-586-4800 ext. 2318

Facility Contacts

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Joanne Stempak, MSc

Role: primary

4165864800 ext. 8399

Jenny Lee, MKin

Role: backup

4165864800 ext. 2318

Other Identifiers

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U01DK062423

Identifier Type: NIH

Identifier Source: secondary_id

View Link

02-0234-E

Identifier Type: -

Identifier Source: org_study_id

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