Clinical trial · Observational
Development and Validation of a Colorectal Cancer Diagnostic Model
Development and Validation of a Colorectal Cancer Diagnostic Model: A Multicenter Study in China (CCDM-CN)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Neoplasia | Neoplasm | CURATED_BROADER | 0.78 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Precision Screening | — | UNRESOLVED | — |
| Prediction Models | — | UNRESOLVED | — |
| Risk Stratification | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Screening Group
- description
- 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.
Primary outcomes (1)
- measure
- Presence of advanced colorectal neoplasia
- timeFrame
- At the time of the index colonoscopy (single time point)
- description
- 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).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available