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RECRUITING
NCT07824791

Prediction of Postoperative Recurrence in Crohn's Disease

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This multicenter prospective observational cohort study aims to develop and validate a multimodal prediction model for postoperative recurrence in patients with Crohn's disease. Patients with Crohn's disease who undergo intestinal resection will be enrolled and followed after surgery. Residual surgical tissue that would otherwise be discarded, together with routinely collected clinical data and biological samples, will be used for research. Multi-omics analyses, including single-cell transcriptomics and spatial transcriptomics, will be performed to identify biological features associated with postoperative recurrence. Participants with Crohn's disease will be followed for clinical, endoscopic, and imaging recurrence after surgery. The study will use data from a screening cohort to develop a prediction model and a validation cohort to evaluate the performance of the model. A control group consisting of patients undergoing intestinal resection for conditions such as colorectal tumors or diverticular disease will also be included for comparative molecular analyses. No treatment will be assigned by the study protocol. All treatment decisions will be made by the treating physicians according to routine clinical practice.

Official title: Prediction Model and Molecular Mechanisms of Postoperative Recurrence in Crohn's Disease

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2025-07-22

Completion Date

2029-06

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

PROCEDURE

Intestinal Resection

Participants undergo intestinal resection as clinically indicated as part of routine medical care. The surgical procedure is not assigned by the study protocol. Residual surgical tissue that would otherwise be discarded may be collected for research analyses.

PROCEDURE

Biospecimen Collection

Residual surgical tissue and biological samples are collected for research. Surgical tissue used for research consists of residual specimens remaining after routine clinical pathological examination. Samples may be used for transcriptomic, single-cell transcriptomic, spatial transcriptomic, proteomic, microbiome, metabolomic, and other multi-omics analyses.

Locations (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China