Development and Validation of a Colorectal Cancer Diagnostic Model

Starting soon

Conditions studied: Colorectal Cancer, Advanced Neoplasia, Prediction Models, Risk Stratification, Precision Screening

In brief

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.

Key facts

Study ID

NCT07692555

Run by

Peking University Cancer Hospital & Institute

People needed

20000

Starts

2026-07-15

Expected to finish

2029-07-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peking University Cancer Hospital & Institute — Beijing, Beijing Municipality, China
• Fujian Provincial Hospital — Fuzhou, Fujian, China
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
• People's Hospital of Ningxia Hui Autonomous Region — Yinchuan, Ningxia, China

Full record on ClinicalTrials.gov

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