Prediction Model and Molecular Mechanisms of Postoperative Recurrence in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Clinical Recurrence Rate at 6 Months
研究概览
简要总结
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.
详细描述
Crohn's disease is characterized by chronic relapsing intestinal inflammation, and a substantial proportion of patients eventually require intestinal resection because of complications such as strictures, penetrating disease, or failure of medical therapy. Postoperative recurrence remains common, but reliable biomarkers and validated prediction models for identifying patients at high risk of recurrence are still lacking.
This is a multicenter, prospective, observational cohort study designed to investigate the predictors and molecular mechanisms of postoperative recurrence in Crohn's disease. The study consists of a screening cohort and a validation cohort. Approximately 200 patients with Crohn's disease undergoing intestinal resection will be enrolled, including 100 participants in the screening cohort and 100 participants in the validation cohort. In addition, approximately 50 patients undergoing intestinal resection for colorectal tumors, diverticular disease, or other non-inflammatory bowel disease conditions will be enrolled as controls.
In the screening cohort, residual surgical specimens that would otherwise be discarded will be collected. Clinical characteristics, follow-up information, biological samples, and multi-omics data will also be collected. Molecular profiling will include analyses such as bulk transcriptomics, single-cell transcriptomics, spatial transcriptomics, proteomics, microbiome analysis, and metabolomics, as applicable. Differences between patients with and without postoperative recurrence will be evaluated, and machine-learning methods will be used to construct a multimodal prediction model.
The validation cohort will be used to evaluate the predictive performance of the multimodal model in a multicenter setting. Postoperative recurrence will be assessed using clinical, endoscopic, and imaging evaluations during follow-up. The study also aims to investigate molecular pathways associated with postoperative recurrence and to identify potential therapeutic targets.
This study is observational. No randomized assignment or protocol-mandated treatment will be provided. Clinical management and postoperative treatment decisions will be made independently by the treating physicians according to routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •1.Patients who require surgical resection of an intestinal segment because of conditions such as colorectal tumors or diverticular disease.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Intestinal Resection (Procedure)
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Intestinal Resection (Procedure)
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Intestinal Resection (Procedure)
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.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Clinical Recurrence Rate at 6 Months
时间窗: 6 months after intestinal resection
Clinical recurrence is defined as the recurrence of clinical manifestations or complications such as abdominal pain, diarrhea, hematochezia, fistula, or perforation, together with a Harvey-Bradshaw Index (HBI) \>4 or Crohn's Disease Activity Index (CDAI) \>150, with recurrence confirmed by endoscopic or imaging assessment. The outcome is reported as the proportion of participants with clinical recurrence.
Endoscopic Recurrence Rate at 6 Months
时间窗: 6 months after intestinal resection
Endoscopic recurrence is defined as a Rutgeerts score of i2 or higher on postoperative endoscopy after complete resection of macroscopically diseased bowel. The outcome is reported as the proportion of participants meeting the criterion for endoscopic recurrence.
次要结局
- Endoscopic Recurrence Rate at 1 Year(1 year after intestinal resection)
- Clinical Recurrence Rate at 1 Year(1 year after intestinal resection)
- Imaging Recurrence Rate at 1 Year(1 year after intestinal resection)
- Imaging Recurrence Rate at 6 Months(6 months after intestinal resection)
- Reoperation or Endoscopic Treatment Rate at 1 Year(1 year after intestinal resection)
研究者
Xiang Gao
Chief Physician, Department of Gastroenterology
Sixth Affiliated Hospital, Sun Yat-sen University