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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Crohn's Disease Cohorts:

‣ Diagnosis of Crohn's disease according to the diagnostic criteria of the Chinese Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing).

⁃ Patients with Crohn's disease who require surgical resection of the diseased intestinal segment because of complications such as stricturing or penetrating disease, or because of failure of medical therapy.

∙ Non-IBD Control Cohort:

• Patients who require surgical resection of an intestinal segment because of conditions such as colorectal tumors or diverticular disease.

Locations
Other Locations
China
The Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Xiang Gao, MD
gxiang@mail.sysu.edu.cn
+86-13502405878
Time Frame
Start Date: 2025-07-22
Estimated Completion Date: 2029-06
Participants
Target number of participants: 250
Treatments
Screening Cohort
Patients with Crohn's disease undergoing clinically indicated intestinal resection. Approximately 100 participants will be enrolled in this cohort. Residual surgical tissue, clinical characteristics, biological samples, and multi-omics data will be collected. Participants will be followed after surgery to identify clinical, endoscopic, and imaging recurrence. Data from this cohort will be used to identify molecular features associated with postoperative recurrence and to develop a multimodal prediction model.
Validation Cohort
Patients with Crohn's disease undergoing clinically indicated intestinal resection. Approximately 100 participants will be enrolled in this multicenter validation cohort and followed after surgery. Clinical, endoscopic, imaging, and biological data will be collected to evaluate the predictive performance of the multimodal model developed in the screening cohort.
Non-IBD Control Cohort
Patients without inflammatory bowel disease who undergo clinically indicated intestinal resection for conditions such as colorectal tumors or diverticular disease. Approximately 50 participants will be enrolled. Residual surgical tissue that would otherwise be discarded will be collected for comparative molecular and multi-omics analyses.
Sponsors
Leads: Sixth Affiliated Hospital, Sun Yat-sen University

This content was sourced from clinicaltrials.gov