Status:
RECRUITING
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
American College of Gastroenterology
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Inflammatory Bowel Diseases
Crohn Disease
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
The aim of this study is to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for Crohn's disease (PRE-Crohn's) tool on behaviors and biomarkers associated wit...
Eligibility Criteria
Inclusion
- Ability to give informed consent
- Ability and willingness to comply with all patient visits and study-related procedures
- Ability to understand and complete study questionnaires
- Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis/IBD unclassified)
- Individuals greater than 14 years of age
Exclusion
- Inability to provide informed consent
- Inability to comply with all patient visits and study-related procedures
- Inability to understand or complete study questionnaires
- Patients with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or indeterminate colitis/IBD unclassified)
- Evidence of clinical signs or symptoms of inflammatory bowel disease, identified by a modified version of the Harvey-Bradshaw Index for CD activity
Key Trial Info
Start Date :
July 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05332639
Start Date
July 14 2025
End Date
May 1 2027
Last Update
January 7 2026
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114