Ibd CAncer and seRious infection in Europe : I-CARE

The major European longitudinal, observational multicenter & prospective cohort study in IBD.

Patient researchers are the success of our I-CARE study.

Thanks to their dedication and their assiduity to provide us monthly information about their disease via online questionnaires (eDiaries), patients were the main actors in the building of a unique and major European database in IBD.

All collected data will allow us to assess prospectively the presence and the extent of safety concerns (cancers and serious infections risks) for anti-TNF or other biologic alone or in combination with thiopurines among IBD patients.

On behalf of I-CARE study team, we warmly thanks all patients as well as all our I-CARE partners who made to this unique project possible.

What does the final I-CARE cohort represent in a few figures ?

For the patients

0
patient researcher’s actors of this project
0
patients contacted for the study purposes
0
eDiaries sent to patients
0
eDiaries completed by patients

For the investigators

0
assessable patients
0
patient – years
0 %
of compliance in the ePRO completion
0
medical reports collected for the coding
0 %
of unresolved queries on Annual Summaries
An Annual summary is a recap of data collected along 12 months of follow-up coming from a patient's ePRO questionnaires. It is dedicated to investigators and serves for the control quality of data collection from patient declaration.

We did it !!! Analysis in progress. Thanks to all patients, investigators, partners
Publication

Agenda of publication

2024-25 Methodology article J.Kirchgesner & S.Sebastian Stelara article Jansen & Excom 2025 Lymphoma in IBDL. Peyrin-Biroulet Colorectal cancer and IBD treatments L. Beaugerie 2026 Impact...
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Physicians tell you about I-CARE

Speakers : Filip Baert, Laurent Beaugerie, Laurent Peyrin-Biroulet, Jean-François Rahier.

Subtitles available in the video settings.

Substudy project assessment

Main steps ?

  • Substudy submission

  • Executive Committee assessment

  • Methodology assessment

  • Form with minor/major comments

  • Presentation and SCI COM vote during international congress

Why ?

To ensure the high quality of I-CARE substudy projects.

Who ?

  1. Executive Committee : L.Peyrin-Biroulet, F. Baert, L. Beaugerie, JF. Rahier
    • To evaluate faisability with I-CARE database (with or without supplementary data).
    • To check the absence of overlap with I-CARE 4 main studies and previously approved substudies (independant project or in collaboration with Executive Committee to work in the main objectives)
  2. Methodologic commitee : C. Baumann (I-CARE methodologist), H. Rousseau (I-CARE statistician)
    J. Kirchgesner (Coding group referent) and Executive Committee members.

    • To validate project methodology (endpoint, statistical analysis plan, design)
    • To ensure compliance with I-CARE database.

From the ICARE study’s database, any investigator can propose a new study project that is called a substudy.
Each substudy project is assessed and validated by the ICARE executive committee and methodology committee before starting.

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