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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other, Procedure, Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients aged between 18 years and 75 years.

• Established diagnosis of CD at least six months prior to study.

• Patients who have undergone intestinal resection within 3 months before study entry or have surgery planned.

Locations
Other Locations
Belgium
University of Leuven
ACTIVE_NOT_RECRUITING
Leuven
Canada
University of Calgary
RECRUITING
Calgary
Germany
University Hospital Erlangen
ACTIVE_NOT_RECRUITING
Erlangen
Ireland
Cork University Hospital
ACTIVE_NOT_RECRUITING
Cork
Mercy University Hospital
ACTIVE_NOT_RECRUITING
Cork
University College Dublin
RECRUITING
Dublin
University College Hospitals Galway
ACTIVE_NOT_RECRUITING
Galway
Israel
Rabin Medical Centre
RECRUITING
Tel Aviv
Italy
ASST Spedali Civili
ACTIVE_NOT_RECRUITING
Brescia
ASST Fatebenefratelli Sacco
RECRUITING
Milan
IRCCS Cà Granda Ospedale Maggiore
RECRUITING
Milan
University Vita-Salute San Raffaele
ACTIVE_NOT_RECRUITING
Milan
University Federico II
RECRUITING
Naples
IRCCS San Matteo
RECRUITING
Pavia
Istituto Clinico Humanitas
ACTIVE_NOT_RECRUITING
Rozzano
Contact Information
Primary
Michelle O'Riordan
moriordan@ucc.ie
+353 (0)21 4901759
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 225
Treatments
Post-operative CD
Patients undergoing surgery or with a previous (within 3 months from the enrolment) surgery for CD
Sponsors
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
Leads: University College Cork

This content was sourced from clinicaltrials.gov