Clinical trial · Observational
Prediction of Postoperative Recurrence in Crohn's Disease
Prediction Model and Molecular Mechanisms of Postoperative Recurrence in Crohn's Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Crohn Disease (CD) | — | UNRESOLVED | — |
| Postoperative Recurrence and Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Intestinal Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Screening Cohort
- description
- 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.
- interventionNames
- Procedure: Intestinal Resection
- Procedure: Biospecimen Collection
- label
- Validation Cohort
- description
- 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.
- interventionNames
- Procedure: Intestinal Resection
- Procedure: Biospecimen Collection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
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