Development and Validation of a Colorectal Cancer Diagnostic Model

July 21, 2026 updated by: Peking University Cancer Hospital & Institute

Development and Validation of a Colorectal Cancer Diagnostic Model: A Multicenter Study in China (CCDM-CN)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Colorectal cancer imposes a heavy disease burden in China. Early detection of colorectal cancer and advanced precancerous lesions can improve clinical outcomes and reduce colorectal cancer mortality. However, colonoscopy, the standard method for screening, is invasive and resource-intensive. A practical, accurate, and clinically applicable risk prediction model may help identify individuals with a higher probability of prevalent colorectal cancer or advanced colorectal neoplasia, support risk-adapted early detection strategies, and optimize resource utilization. Yet existing diagnostic and risk prediction tools have been developed primarily in Western populations and demonstrate limited applicability to Chinese individuals.

This study is designed as a multicenter, observational, and cross-sectional study enrolling adults aged 18-80 years who are already scheduled to undergo colonoscopy during routine clinical care at participating hospitals. The study does not assign participants to any medical intervention and does not determine whether they should undergo colonoscopy. All decisions regarding the colonoscopy, including the timing, conduct of the procedure, pathology evaluation, and subsequent clinical care, are made by the treating clinicians following the routine clinical pathway of the respective participating institution.

After providing informed consent, eligible participants will complete a standardized electronic questionnaire before colonoscopy. The questionnaire will collect candidate predictors, including demographics, lifestyle and behavioral factors (e.g., smoking, alcohol consumption, physical activity, diet), personal and family medical history, and gastrointestinal symptoms. After the index clinical procedure, clinical colonoscopy and pathology reports will be abstracted. The main outcome is prevalent colorectal advanced neoplasia at the index colonoscopy, including colorectal carcinoma, advanced adenoma (adenoma ≥10 mm, or with high-grade dysplasia, or with villous/tubulovillous histology), and advanced serrated adenoma (traditional serrated adenoma or sessile serrated adenoma ≥10 mm or with high-grade dysplasia).

At least 20,000 participants will be enrolled across multiple sites, including Peking University Cancer Hospital & Institute, the First Affiliated Hospital of Xiamen University, Fujian Provincial Hospital, Ningxia Hui Autonomous Region People's Hospital, and other collaborating institutions. Participants are enrolled competitively until the total sample size is reached.

The sample size was determined to support the development and validation of a multivariable risk prediction model, following the framework proposed by Riley et al. We adopted a conservative set of assumptions, with an expected prevalence of advanced colorectal neoplasia of approximately 6%, an anticipated model discrimination (AUC) in the range of 0.65 to 0.70, and approximately 40 candidate predictor parameters covering demographics, lifestyle factors, personal and family medical history, prior colonoscopy history, and gastrointestinal symptoms. The minimum sample size required for model development is estimated at 9,000 to 13,500 participants. After reserving 20% to 30% of enrolled participants for internal validation, the total required sample size increases to approximately 11,000 to 19,000. To further accommodate potential incomplete data, non-evaluable outcomes, and multi-center external validation, the final enrollment target was set at a minimum of 20,000 participants.

Candidate prediction models will be developed using logistic regression and machine-learning algorithms. Internal validation will be performed using cross-validation and bootstrap methods. External validation will be performed across participating centers. Model performance will be assessed using the area under the receiver operating characteristic curve, calibration measures, and decision-curve analysis. The final model and risk stratification scheme will be selected based on predictive performance, stability, interpretability, feasibility, and data-collection burden. This scheme will then be translated into a practical tool for clinical and public health settings to guide individualized colorectal cancer screening strategies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Peking University Cancer Hospital & Institute
        • Principal Investigator:
          • Zhonghu He, PhD
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Xiaoling Zheng, PhD
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University
        • Contact:
        • Principal Investigator:
          • Haixing Wang, PhD
    • Ningxia
      • Yinchuan, Ningxia, China, 750001
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
          • Shengjuan Hu, Master of Medicine
          • Phone Number: +86-0951-5920120
          • Email: hsj.judy@163.com
        • Principal Investigator:
          • Shengjuan Hu, Master of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Presence of advanced colorectal neoplasia
Time Frame: At the time of the index colonoscopy (single time point)

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Predictive performance of the risk model (exploratory)
Time Frame: Assessed once after model development and validation are completed (approximately 2-3 years after study start).
Area under the receiver operating characteristic curve (AUC) of the final model for predicting advanced colorectal neoplasia, assessed through internal and external validation.
Assessed once after model development and validation are completed (approximately 2-3 years after study start).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Cancer Hospital & Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fujian Provincial Hospital
The First Affiliated Hospital of Xiamen University
People's Hospital of Ningxia Hui Autonomous Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhonghu He, PhD, Peking University Cancer Hospital & Institute
  • Principal Investigator: Haixing Wang, PhD, The First Affiliated Hospital of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LGH2026178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly due to data privacy and confidentiality requirements as stated in the informed consent form and institutional policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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