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NCT Number: NCT07078032

A Randomized Controlled Trial Evaluating the Effectiveness of a Novel Risk-Stratified Screening Strategy for Lung Cancer

A nationwide population-based multi-center RCT enrolling ≥60,000 eligible residents to compare screening effectiveness between risk-prediction-model-driven and traditional guideline-based high-risk lung cancer screening strategies.

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Key information

Conditions

Lung Cancer Screening

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Residents with local household registration residing continuously in the region for ≥3 years.
  • Aged 40-74 years at enrollment.

Exclusion criteria

  • Prior diagnosis of lung cancer (histologically/cytologically confirmed)
  • Currently receiving active treatment for any malignancy.
  • Presence of severe comorbidities with life expectancy <5 years
  • Participation in any lung cancer screening program within 5 years.
  • Functional dependency (ADL score ≤2) OR unwillingness to comply with protocol-required follow-up.
  • Declined to provide written informed consent.

Treatment and study plan

Prediction Model Arm

Diagnostic Test

Lung cancer risk stratification via prediction model integrating: advanced age, lung cancer family history, personal cancer history, childhood coal exposure, asthma history, and food allergy history. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases.

Other names: Lung Cancer Risk Prediction Model Arm

Standard Screening Arm

Diagnostic Test

Participants are screened based on NCCN guideline criteria. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases.

Other names: Traditional High-Risk Factors Arm

Primary outcomes

  1. Positive Predictive Value (PPV) of Screening Strategies

    Time frame: From enrollment through completion of diagnostic confirmation (up to 3 months post-screening)

    Proportion of true lung cancer cases among participants with positive screening results, confirmed by histopathology within 3 months after screening. Calculated as: (True Positives) / (True Positives + False Positives) × 100%. Assessed separately for both screening arms.

Secondary outcomes

  1. Sensitivity of Screening Strategies

    Time frame: From screening to 12-month follow-up

    Proportion of true lung cancer cases correctly identified by screening, confirmed through histopathology within 6 months. Calculated as: True Positives / (True Positives + False Negatives) × 100%. Includes interval cancers detected within 12 months post-screening

  2. Specificity of Screening Strategies

    Time frame: From screening to 12-month follow-up

    Proportion of cancer-free participants correctly identified as screening-negative. Calculated as: True Negatives / (True Negatives + False Positives) × 100%. Cancer-free status confirmed by 12-month follow-up

  3. Negative Predictive Value (NPV)

    Time frame: From screening to 12-month follow-up

    Proportion of screening-negative participants without lung cancer. Calculated as: True Negatives / (True Negatives + False Negatives) × 100%. Absence of cancer confirmed by 12-month follow-up including LDCT and clinical evaluation.

  4. Early-Stage Shift Proportion

    Time frame: At time of cancer diagnosis (within 3 months post-positive screening)

    Percentage of screen-detected lung cancer cases diagnosed at early stage (AJCC 8th ed. Stage I-II) versus late stage (Stage III-IV). Calculated as: (Early-stage cases) / (Total screen-detected cases) × 100%.

  5. Lung Cancer-Specific Mortality Rate

    Time frame: From randomization to 3-year follow-up

    Death rate attributable to lung cancer, verified by independent mortality review committee using ICD-10 codes (C34.0-C34.9) and medical records. Expressed as deaths per 1,000 person-years.

  6. Overall Survival in Screen-Detected Lung Cancer

    Time frame: From cancer diagnosis to 3-year follow-up

    Time from pathological diagnosis of lung cancer to death from any cause. Assessed using Kaplan-Meier method with censoring at last follow-up. Reported as median survival with 95% CI.

Study contacts

Contact information is provided by the study sponsor or research team.

Huiting Wang

CONTACT

[email protected]

+86 15622132598

Wenhua Liang professor, doctor

CONTACT

[email protected]

+86 020-83062808

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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