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

Guangzhou Medical University

Status: Not yet enrolling

Conditions: Lung Cancer Screening

Treatments: Diagnostic Test: Prediction Model Arm; Diagnostic Test: Standard Screening Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT07078032

20250711

Details and patient eligibility

About

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.

Enrollment: 60,000 estimated patients

Sex: All

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60,000 participants in 2 patient groups

Prediction Model Arm

Experimental group

Description:

Lung Cancer Risk Prediction Model Arm

Treatment:

Diagnostic Test: Prediction Model Arm

Standard Screening Arm

Active Comparator group

Description:

Traditional High-Risk Factors Arm

Treatment:

Diagnostic Test: Standard Screening Arm