Development and Validation of a Colorectal Cancer Diagnostic Model

NCT07692555 | Not Yet Recruiting DMC

• 1 other identifier: LGH2026178
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 4

Brief Summary

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

Colorectal Cancer; Advanced Neoplasia; Prediction Models; Risk Stratification; Precision Screening

Keywords

Colorectal cancer; Colorectal Advanced Neoplasia; Precision Screening; Risk Stratification

Outcome Measures

Primary Outcomes (1)

• Presence of advanced colorectal neoplasia

  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)

Secondary Outcomes (1)

• Predictive performance of the risk model (exploratory)

  Assessed once after model development and validation are completed (approximately 2-3 years after study start).

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: collaborator
• Fujian Provincial Hospital: collaborator
• People's Hospital of Ningxia Hui Autonomous Region: collaborator
• Peking University Cancer Hospital & Institute: lead

Study Sites (4)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, 750001, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Zhonghu He, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Haixing Wang, PhD

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhonghu He, PhD

CONTACT

+86-010-88196762; Zhonghuhe@foxmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)