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Development and Validation of a Colorectal Cancer Diagnostic Model

2026年7月21日 更新者：Peking University Cancer Hospital & Institute

Development and Validation of a Colorectal Cancer Diagnostic Model: A Multicenter Study in China (CCDM-CN)

This is a multicenter, observational study designed to develop and validate a diagnostic model for colorectal cancer and advanced colorectal neoplasia among adults undergoing routine-care colonoscopy in the Chinese population.

The study will enroll adults aged 18 to 80 years who have already been scheduled or planned to undergo colonoscopy according to routine clinical care, physical examination, or screening pathways at participating medical institutions. The study will not invite, organize, require, or otherwise arrange colonoscopy for any participant. Colonoscopy, bowel preparation, anesthesia assessment, biopsy, pathology examination, and subsequent clinical management will be performed solely according to the existing clinical pathway of each participating institution.

After informed consent, participants will be invited to complete a standardized electronic questionnaire before their scheduled colonoscopy. The questionnaire will collect self-reported information on demographic characteristics, lifestyle factors, environmental exposures, personal medical history, family history of colorectal cancer, prior colonoscopy history, and gastrointestinal symptoms. The study team will also abstract colonoscopy and pathology results from medical records. No additional biological specimens will be collected for research purposes.

The primary clinical outcome is prevalent colorectal advanced neoplasia, defined as colorectal cancer, advanced colorectal adenoma, or advanced colorectal serrated lesion identified through colonoscopy and associated pathology. Statistical and machine-learning approaches will be used to develop and validate diagnostic models. Model performance will be evaluated by discrimination, calibration, and clinical net benefit in internal validation and multicenter external validation.

研究概览

地位

尚未招聘

条件

详细说明

Colorectal cancer imposes a heavy disease burden in China. Early detection of colorectal cancer and advanced precancerous lesions can improve clinical outcomes and reduce colorectal cancer mortality. However, colonoscopy, the standard method for screening, is invasive and resource-intensive. A practical, accurate, and clinically applicable risk prediction model may help identify individuals with a higher probability of prevalent colorectal cancer or advanced colorectal neoplasia, support risk-adapted early detection strategies, and optimize resource utilization. Yet existing diagnostic and risk prediction tools have been developed primarily in Western populations and demonstrate limited applicability to Chinese individuals.

This study is designed as a multicenter, observational, and cross-sectional study enrolling adults aged 18-80 years who are already scheduled to undergo colonoscopy during routine clinical care at participating hospitals. The study does not assign participants to any medical intervention and does not determine whether they should undergo colonoscopy. All decisions regarding the colonoscopy, including the timing, conduct of the procedure, pathology evaluation, and subsequent clinical care, are made by the treating clinicians following the routine clinical pathway of the respective participating institution.

After providing informed consent, eligible participants will complete a standardized electronic questionnaire before colonoscopy. The questionnaire will collect candidate predictors, including demographics, lifestyle and behavioral factors (e.g., smoking, alcohol consumption, physical activity, diet), personal and family medical history, and gastrointestinal symptoms. After the index clinical procedure, clinical colonoscopy and pathology reports will be abstracted. The main outcome is prevalent colorectal advanced neoplasia at the index colonoscopy, including colorectal carcinoma, advanced adenoma (adenoma ≥10 mm, or with high-grade dysplasia, or with villous/tubulovillous histology), and advanced serrated adenoma (traditional serrated adenoma or sessile serrated adenoma ≥10 mm or with high-grade dysplasia).

At least 20,000 participants will be enrolled across multiple sites, including Peking University Cancer Hospital & Institute, the First Affiliated Hospital of Xiamen University, Fujian Provincial Hospital, Ningxia Hui Autonomous Region People's Hospital, and other collaborating institutions. Participants are enrolled competitively until the total sample size is reached.

The sample size was determined to support the development and validation of a multivariable risk prediction model, following the framework proposed by Riley et al. We adopted a conservative set of assumptions, with an expected prevalence of advanced colorectal neoplasia of approximately 6%, an anticipated model discrimination (AUC) in the range of 0.65 to 0.70, and approximately 40 candidate predictor parameters covering demographics, lifestyle factors, personal and family medical history, prior colonoscopy history, and gastrointestinal symptoms. The minimum sample size required for model development is estimated at 9,000 to 13,500 participants. After reserving 20% to 30% of enrolled participants for internal validation, the total required sample size increases to approximately 11,000 to 19,000. To further accommodate potential incomplete data, non-evaluable outcomes, and multi-center external validation, the final enrollment target was set at a minimum of 20,000 participants.

Candidate prediction models will be developed using logistic regression and machine-learning algorithms. Internal validation will be performed using cross-validation and bootstrap methods. External validation will be performed across participating centers. Model performance will be assessed using the area under the receiver operating characteristic curve, calibration measures, and decision-curve analysis. The final model and risk stratification scheme will be selected based on predictive performance, stability, interpretability, feasibility, and data-collection burden. This scheme will then be translated into a practical tool for clinical and public health settings to guide individualized colorectal cancer screening strategies.

研究类型

观察性的

注册 (估计的)

20000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • Peking University Cancer Hospital & Institute
        • 首席研究员：
          • Zhonghu He, PhD
        • 接触：
    • Fujian
      • Fuzhou、Fujian、中国、350001
        • Fujian Provincial Hospital
        • 接触：
        • 首席研究员：
          • Xiaoling Zheng, PhD
      • Xiamen、Fujian、中国、361003
        • The First Affiliated Hospital of Xiamen University
        • 接触：
        • 首席研究员：
          • Haixing Wang, PhD
    • Ningxia
      • Yinchuan、Ningxia、中国、750001
        • People's Hospital of Ningxia Hui Autonomous Region
        • 接触：
          • Shengjuan Hu, Master of Medicine
          • 电话号码：+86-0951-5920120
          • 邮箱：hsj.judy@163.com
        • 首席研究员：
          • Shengjuan Hu, Master of Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Adults aged 18 to 80 years who have already been scheduled for or referred to colonoscopy as part of routine clinical care, physical examination, or screening pathways at participating medical institutions in China will be enrolled. All participants must be willing and able to provide informed consent and complete a standardized risk factor questionnaire before the colonoscopy procedure. This population is selected because the primary study outcome, i.e., the presence of advanced colorectal neoplasia, must be confirmed by colonoscopy and histopathology, which are available through routine clinical care without requiring additional invasive procedures for research purposes.

描述

Inclusion Criteria:

  • Age between 18 and 80 years at the time of enrollment.
  • Already scheduled to undergo colonoscopy according to routine clinical care, physical examination, or screening pathways at a participating medical institution.
  • No prior history of colorectal cancer or advanced colorectal neoplasia.
  • No contraindications to colonoscopy (as determined by the treating physician).
  • Able to understand the study information and complete the colorectal cancer risk-factor questionnaire independently or with appropriate assistance.
  • Willing to provide informed consent for completion of the questionnaire and for collection of routine clinical colonoscopy, pathology, and related medical-record data.

Exclusion Criteria:

  • The baseline colorectal cancer risk-factor questionnaire is not completed, or considered invalid because of substantial missing or inconsistent information.
  • The scheduled index colonoscopy is cancelled, not performed, or not completed regardless of the underlying reason (e.g., inadequate bowel preparation).
  • Incomplete or unavailable colonoscopy or pathology data after the procedure.
  • Refusal or withdrawal of informed consent.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Screening Group
Adults aged 18 to 80 years who have already been scheduled for or referred to colonoscopy as part of routine clinical care, physical examination, or screening pathways at participating medical institutions in China will be enrolled. The study will not invite, organize, require, or otherwise arrange colonoscopy. Participation in the study will only involve informed consent, completion of a standardized questionnaire before colonoscopy, and collection of routine clinical colonoscopy and pathology data from medical records. No randomization or experimental intervention will be performed.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Presence of advanced colorectal neoplasia
大体时间：At the time of the index colonoscopy (single time point)

Presence or absence of colorectal advanced neoplasia identified through routine clinical colonoscopy and associated pathology reports. Colorectal advanced neoplasia is defined as the presence of at least one of the following upon the index colonoscopy and confirmed by histopathology:

  1. Colorectal adenocarcinoma;
  2. Advanced adenoma (tubular, tubulovillous, or villous adenoma with any of these features: size ≥10 mm, high-grade dysplasia, or villous/tubulovillous histology);
  3. Advanced serrated adenoma (traditional serrated adenoma or sessile serrated adenoma ≥10 mm, or with high-grade dysplasia).
At the time of the index colonoscopy (single time point)

次要结果测量

结果测量
措施说明
大体时间
Predictive performance of the risk model (exploratory)
大体时间：Assessed once after model development and validation are completed (approximately 2-3 years after study start).
Area under the receiver operating characteristic curve (AUC) of the final model for predicting advanced colorectal neoplasia, assessed through internal and external validation.
Assessed once after model development and validation are completed (approximately 2-3 years after study start).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Peking University Cancer Hospital & Institute

合作者

Fujian Provincial Hospital
The First Affiliated Hospital of Xiamen University
People's Hospital of Ningxia Hui Autonomous Region

调查人员

  • 首席研究员：Zhonghu He, PhD、Peking University Cancer Hospital & Institute
  • 首席研究员：Haixing Wang, PhD、The First Affiliated Hospital of Xiamen University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月15日

初级完成 (估计的)

2028年7月30日

研究完成 (估计的)

2029年7月1日

研究注册日期

首次提交

2026年7月3日

首先提交符合 QC 标准的

2026年7月3日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月23日

上次提交的符合 QC 标准的更新

2026年7月21日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • LGH2026178

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared publicly due to data privacy and confidentiality requirements as stated in the informed consent form and institutional policy.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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