Prediction of Postoperative Recurrence in Crohn's Disease
Prediction Model and Molecular Mechanisms of Postoperative Recurrence in Crohn's Disease
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Xiang Gao, MD
- 電話番号：+86-13502405878
- メール：gxiang@mail.sysu.edu.cn
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510655
- 募集
- The Sixth Affiliated Hospital, Sun Yat-sen University
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コンタクト：
- Xiang Gao, MD
- 電話番号：+86-13502405878
- メール：gxiang@mail.sysu.edu.cn
-
コンタクト：
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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:
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:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
Participants undergo intestinal resection as clinically indicated as part of routine medical care.
The surgical procedure is not assigned by the study protocol.
Residual surgical tissue that would otherwise be discarded may be collected for research analyses.
Residual surgical tissue and biological samples are collected for research.
Surgical tissue used for research consists of residual specimens remaining after routine clinical pathological examination.
Samples may be used for transcriptomic, single-cell transcriptomic, spatial transcriptomic, proteomic, microbiome, metabolomic, and other multi-omics analyses.
|
|
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.
|
Participants undergo intestinal resection as clinically indicated as part of routine medical care.
The surgical procedure is not assigned by the study protocol.
Residual surgical tissue that would otherwise be discarded may be collected for research analyses.
Residual surgical tissue and biological samples are collected for research.
Surgical tissue used for research consists of residual specimens remaining after routine clinical pathological examination.
Samples may be used for transcriptomic, single-cell transcriptomic, spatial transcriptomic, proteomic, microbiome, metabolomic, and other multi-omics analyses.
|
|
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.
|
Participants undergo intestinal resection as clinically indicated as part of routine medical care.
The surgical procedure is not assigned by the study protocol.
Residual surgical tissue that would otherwise be discarded may be collected for research analyses.
Residual surgical tissue and biological samples are collected for research.
Surgical tissue used for research consists of residual specimens remaining after routine clinical pathological examination.
Samples may be used for transcriptomic, single-cell transcriptomic, spatial transcriptomic, proteomic, microbiome, metabolomic, and other multi-omics analyses.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinical Recurrence Rate at 6 Months
時間枠：6 months after intestinal resection
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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.
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6 months after intestinal resection
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Endoscopic Recurrence Rate at 6 Months
時間枠：6 months after intestinal resection
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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.
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6 months after intestinal resection
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Endoscopic Recurrence Rate at 1 Year
時間枠：1 year after intestinal resection
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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.
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1 year after intestinal resection
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Clinical Recurrence Rate at 1 Year
時間枠：1 year after intestinal resection
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Clinical recurrence is defined as 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.
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1 year after intestinal resection
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Imaging Recurrence Rate at 1 Year
時間枠：1 year after intestinal resection
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Imaging recurrence is defined as a score of 2 or higher on computed tomography enterography (CTE) or magnetic resonance enterography (MRE) after surgical resection of the diseased bowel.
The outcome is reported as the proportion of participants meeting the imaging recurrence criterion.
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1 year after intestinal resection
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Imaging Recurrence Rate at 6 Months
時間枠：6 months after intestinal resection
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Imaging recurrence is defined as a score of 2 or higher on computed tomography enterography (CTE) or magnetic resonance enterography (MRE) after surgical resection of the diseased bowel.
The outcome is reported as the proportion of participants meeting the imaging recurrence criterion.
|
6 months after intestinal resection
|
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Reoperation or Endoscopic Treatment Rate at 1 Year
時間枠：1 year after intestinal resection
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The outcome is defined as the proportion of participants who require repeat intestinal resection or endoscopic treatment because of Crohn's disease recurrence after the index intestinal resection.
Stoma reversal procedures and surgeries for perianal disease are not counted as outcome events.
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1 year after intestinal resection
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- G2025005
- 2025ZSLYEC-290 (その他の識別子：Ethics Committee of The Sixth Affiliated Hospital, Sun Yat-sen University)
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