Prediction of postoperative recurrence in Crohn's disease after surgery
Official title: Prediction Model and Molecular Mechanisms of Postoperative Recurrence in Crohn's Disease
Run by Sixth Affiliated Hospital, Sun Yat-sen University · NCT07824791 · Data updated 2026-11-12
A multicenter study will test a multimodal model to predict which Crohn's patients are likely to have disease recur after intestinal resection.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | July 22, 2025 |
| Main results expected | December 2028 |
| Study ends | June 2029 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT07824791 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with Crohn's disease requiring intestinal resection, per the Chinese Consensus criteria, and who have no conflicting autoimmune conditions.
✕Probably not a fit
Patients without postoperative recurrence or whose recurrence is not predicted by the model may not benefit from risk stratification.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, prospective observational cohort study focused on Crohn's disease patients undergoing intestinal resection. Researchers will collect residual surgical tissue along with standard clinical data and various biological samples to perform multi-omics analyses, including single-cell and spatial transcriptomics, to identify features linked to recurrence. A screening cohort will help develop a prediction model, and a separate validation cohort will evaluate its performance, with a non-IBD surgical control group included for comparison. The goal is to understand predictors and molecular mechanisms of postoperative recurrence to improve risk stratification. Patients will be followed clinically, endoscopically, and through imaging to monitor for recurrence.
Why it matters
Potential benefit: If successful, the model could help identify patients at high risk of recurrence and tailor post-surgical care accordingly.
How similar studies have gone: Other studies have shown that multi-omics and transcriptomic data can reveal recurrence-associated signals in Crohn's disease, though this exact predictive approach is novel for postoperative recurrence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Crohn's Disease Cohorts: 1. Diagnosis of Crohn's disease according to the diagnostic criteria of the Chinese Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing). 2. 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: 1.Patients who require surgical resection of an intestinal segment because of conditions such as colorectal tumors or diverticular disease. Exclusion Criteria: * Crohn's Disease Cohorts: 1. Uncertain diagnosis of Crohn's disease. 2. Clinical history or medical records are substantially incomplete, making it impossible to determine the time of recurrence or whether postoperative recurrence occurred. Non-IBD Control Cohort: 1. Coexisting inflammatory bowel disease or other rheumatic or autoimmune diseases. 2. Substantially incomplete clinical history or medical records.
Where it's running
-
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Xiang Gao, MD
- Email: gxiang@mail.sysu.edu.cn
- Phone: +86-13502405878
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.