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Development and Validation of a Colorectal Cancer Diagnostic Model

NCT07692555 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2026-07-23

No results posted yet for this study

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    collaborator OTHER

  • Fujian Provincial Hospital

    collaborator OTHER

  • People's Hospital of Ningxia Hui Autonomous Region

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Zhonghu He, PhD · Peking University Cancer Hospital & Institute

  • Haixing Wang, PhD · The First Affiliated Hospital of Xiamen University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2028-07-30
Completion
2029-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07692555 on ClinicalTrials.gov