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Studies

Observational Recruiting

NCT06505304 on ClinicalTrials.gov

AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease

Official title: Endoscopic Multimodal Assessment Using Advanced Imaging Integrated AI to Predict Recurrence in pOSt-oPerativE CRohn's Disease - PROSPER Study

  • Sponsor: University College Cork
  • Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
  • Enrollment: 225 (Estimated)
  • Study start: 2024-05-01 (Actual)
  • Primary completion: 2025-10-31 (Estimated)
  • Study completion: 2026-05-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

This is a multicentre prospective international observational study. This study aims to introduce a novel multidimensional approach to precision imaging, enabling the identification and stratification of high-risk patients who can potentially benefit from early treatments to halt the progression of Crohn's disease (CD). The investigators will develop a novel endoscopic assessment system using endoscopic enhanced imaging (EEI) to evaluate early post-surgical changes and predict post-operative CD recurrence (POCr). By integrating with immune marker profiling, clinical data, and AI assessment of EEI and histology, the investigators further plan to improve risk stratification and reduce interobserver variability.

Conditions

  • Crohn Disease

Intervention / Treatment

  • Procedure: Colonoscopy
  • Procedure: Intestinal biopsies
  • Procedure: Confocal laser endomicroscopy
  • Procedure: Intestinal ultrasound
  • Diagnostic Test: Stool
  • Diagnostic Test: Blood
  • Diagnostic Test: Saliva
  • Other: Clinical follow-up

Primary Outcome Measures

  • Early post-operative endoscopic recurrence (3 months or 6 months)
    Post surgical endoscopic recurrence will be defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \> 2 and Rutgeerts score \> i2a
  • Early post-operative clinical recurrence (3 months and 6 months)
    Post surgical clinical recurrence will be defined as: * CD Activity Index score (CDAI) \>200 and a \>70-point increase from baseline, or * development of a new or re-draining fistula or abscess, or * requiring steroids, endoscopic dilatation, or hospitalization

Countries

Belgium, Canada, Germany, Ireland, Israel, Italy

Locations and Investigators

  • University of Leuven, Leuven, Belgium (Active not recruiting)
  • University of Calgary, Calgary, Canada (Recruiting)
    • Cathy Liu
    • Remo Panaccione, Professor (Principal Investigator)
  • University Hospital Erlangen, Erlangen, Germany (Active not recruiting)
  • Cork University Hospital, Cork, Ireland (Active not recruiting)
  • Mercy University Hospital, Cork, Ireland (Active not recruiting)
  • University College Dublin, Dublin, Ireland (Recruiting)
    • Janet Rebollos
    • Glen Doherty, Professor (Principal Investigator)
  • University College Hospitals Galway, Galway, Ireland (Active not recruiting)
  • Rabin Medical Centre, Tel Aviv, Israel (Recruiting)
  • Istituto Clinico Humanitas, Rozzano, Italy (Active not recruiting)
  • ASST Spedali Civili, Brescia, Italy (Active not recruiting)
  • ASST Fatebenefratelli Sacco, Milan, Italy (Recruiting)
    • Rosanna Cannatelli
    • Rosanna Cannatelli, Dr (Principal Investigator)
  • IRCCS Cà Granda Ospedale Maggiore, Milan, Italy (Recruiting)
    • Gianeugenio Tontini, Professor
    • Gianeugenio Tontini, Professor (Principal Investigator)
  • University Vita-Salute San Raffaele, Milan, Italy (Active not recruiting)
  • University Federico II, Naples, Italy (Recruiting)
    • Olga Maria Nardone, Dr
    • Fabiana Castiglione, Professor (Principal Investigator)
  • IRCCS San Matteo, Pavia, Italy (Recruiting)
    • Mariangela Delliponti
    • Antonio Di Sabatino, Professor (Principal Investigator)

Study Officials

  • Marietta Iacucci, Professor (Study Chair) — APC Microbiome Ireland, University College Cork