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Development and Validation of a Colorectal Cancer Diagnostic Model

21. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

20000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Presence of advanced colorectal neoplasia
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Predictive performance of the risk model (exploratory)
Zeitfenster: 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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Peking University Cancer Hospital & Institute

Mitarbeiter

Fujian Provincial Hospital
The First Affiliated Hospital of Xiamen University
People's Hospital of Ningxia Hui Autonomous Region

Ermittler

  • Hauptermittler: Zhonghu He, PhD, Peking University Cancer Hospital & Institute
  • Hauptermittler: Haixing Wang, PhD, The First Affiliated Hospital of Xiamen University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juli 2026

Primärer Abschluss (Geschätzt)

30. Juli 2028

Studienabschluss (Geschätzt)

1. Juli 2029

Studienanmeldedaten

Zuerst eingereicht

3. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juli 2026

Zuerst gepostet (Tatsächlich)

9. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • LGH2026178

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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