Prediction of Postoperative Recurrence in Crohn's Disease
Recruiting · NCT07824791 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Crohn's Disease Cohorts:
- Uncertain diagnosis of Crohn's disease.
- 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:
- Coexisting inflammatory bowel disease or other rheumatic or autoimmune diseases.
- Substantially incomplete clinical history or medical records.
Where it is running
1 location listed.
- The Sixth Affiliated Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China