Status:
RECRUITING
Ibd CAncer and seRious Infections in France (I-CARE 2)
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborating Sponsors:
Sanoia
Conditions:
IBD
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Brief Summary
This is a French prospective longitudinal observational multicentre cohort study. Primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infection...
Detailed Description
Number of patients : 6 000 at least Participating investigators : 250 at least Recruitment period : 3 years 6 months Primary objective : to assess prospectively the presence and the extent of safety...
Eligibility Criteria
Inclusion
- Patient with an established diagnosis of Crohn's disease, ulcerative colitis or IBD unclassified based on usual radiological, endoscopic or histological criteria.
- Patient aged 18 and older accepting to sign the informed participating consent form, stating that he accepts to provide personal details (mobile and home phone number, e-mail address), to complete the e-PRO as required and to be contacted by a Study Coordinator and his gastroenterologist for the purpose of the study during the entire study period and during follow up if required.
Exclusion
- Patient unable to sign the informed consent form
- Patient with no regular access to internet
- Patient refusing to sign the informed consent form
- Patient enrolled in a Randomized Clinical Trial (If the investigational product received was blinded, and if the treatment is unknown at time of enrolment in I-CARE 2)
Key Trial Info
Start Date :
January 25 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT06089590
Start Date
January 25 2024
End Date
March 1 2031
Last Update
March 14 2025
Active Locations (2)
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1
CHU Amiens Picardie
Amiens, France, 80000
2
APHP Hôpital Saint Antoine
Paris, France, 75012