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Clinnova-IBD, a Prospective Cohort of Patients With Inflammatory Bowel Disease (IBD)

NCT05733702 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-09-22

No results posted yet for this study

Summary

This study is part of the Clinnova program. This is a prospective cohort study including patients with IBD recruited at the time of a treatment change.

At least 800 participants (recruited in France, Germany and Luxembourg) will be enrolled, of which 100 participants are expected to be recruited in Luxembourg with the present study protocol.

The mission of Clinnova is to support the digitalization of healthcare and precision medicine by creating a data-enabling environment for accessing, sharing and analyzing interoperable, high-quality health data.

The main hypothesis is that treatment change decided by clinicians is predictable using objective surrogate markers derived from clinical, epidemiological, and omics data. Identifying these objective markers may facilitate future treatment decisions, provide new insights on the molecular causes for differential treatment response, pathogenesis and progression, and potential pointers for improved personalized therapeutic interventions.

Conditions

  • Inflammatory Bowel Diseases

Interventions

OTHER

All participants will be asked to provide data and samples for collection and analysis.

During the first year from the date of inclusion, data related to demographics, lifestyle, laboratory and physical examinations will be collected at baseline, at 3 months, and at 12 months. Patient-Reported Outcomes (PROs) with voice recordings will be collected at different time points in-between clinical visits using the Colive application. Participants will be asked to provide biological samples (i.e., blood, dried blood spots and stool are mandatory; saliva, urine and hair are optional), tissue samples from endoscopic biopsy and imaging data (if performed as per standard of care) at three timepoints (baseline; 3 months; 12 months). One unscheduled visit may be included in the study in case of occurrence of flare or treatment change.A long-term follow-up (starting from month 12 and up to 4 years after month 12) will include the collection of medical data on a yearly basis, collection of PROs with voice recording every 6 months and continuous collection of data using the smartwatch.

Sponsors & Collaborators

  • Luxembourg National Research Fund

    collaborator UNKNOWN

  • Centre Hospitalier du Luxembourg

    collaborator OTHER

  • Hôpitaux Robert Schuman

    collaborator UNKNOWN

  • University of Luxembourg

    collaborator OTHER

  • Luxembourg Institute of Health

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2029-11-30
Completion
2029-11-30

Countries

  • Luxembourg

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05733702 on ClinicalTrials.gov