Ibd CAncer and seRious Infections in France (I-CARE 2)
Observational · No treatment assigned · 2 sites · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: IBD, Ulcerative Colitis and Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 6000 participants are expected to take part.
- Start date: 2024-01-25.
- Main results expected around 2031-03-01 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in France.
Main thing being measured
- Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events) (4 to 7.5 years)
In the researchers’ words
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 infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | IBD; Ulcerative Colitis; Crohn Disease |
| Lead sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| Collaborators | Sanoia |
| Enrollment | 6000 (estimated) |
| Start date | 2024-01-25 |
| Primary completion (est.) | 2031-03-01 |
| First posted | 2023-10-18 |
| Last updated | 2025-03-14 |
| Official title | Ibd CAncer and seRious Infections in France (I-CARE 2) |
| ClinicalTrials.gov ID | NCT06089590 |
Interventions
- Non-interventional (Other)
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Criteria: * 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)
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Picardie | Amiens | France | Recruiting |
| APHP Hôpital Saint Antoine | Paris | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.