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

ConditionLung Cancer Screening
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-74
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Residents with local household registration residing continuously in the region for ≥3 years.

Aged 40-74 years at enrollment.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60,000 Participants
are divided into 2 treatment groups
Group A: Prediction Model ArmExperimental treatment 1 intervention
Group B: Standard Screening ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Positive Predictive Value (PPV) of Screening Strategies

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.

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

Secondary outcomes

1

Sensitivity of Screening Strategies

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

Time frame
From screening to 12-month follow-up
2

Specificity of Screening Strategies

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

Time frame
From screening to 12-month follow-up
3

Negative Predictive Value (NPV)

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.

Time frame
From screening to 12-month follow-up
4

Early-Stage Shift Proportion

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%.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: