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.
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).
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.
Peking University Cancer Hospital & Institute
Lead sponsor
The First Affiliated Hospital of Xiamen University
Collaborator
Fujian Provincial Hospital
Collaborator
People's Hospital of Ningxia Hui Autonomous Region
Collaborator