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

NCT07078032 | Not Yet Recruiting

• 1 other identifier: 20250711
• Study Type: interventional
• Target: 60,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lung Cancer Screening

Outcome Measures

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.

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

Secondary Outcomes (6)

• Sensitivity of Screening Strategies

  From screening to 12-month follow-up

• Specificity of Screening Strategies

  From screening to 12-month follow-up

• Negative Predictive Value (NPV)

  From screening to 12-month follow-up

• Early-Stage Shift Proportion

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

• Lung Cancer-Specific Mortality Rate

  From randomization to 3-year follow-up

Study Arms (2)

Prediction Model Arm

EXPERIMENTAL

Lung Cancer Risk Prediction Model Arm

Diagnostic Test: Prediction Model Arm

Standard Screening Arm

ACTIVE COMPARATOR

Traditional High-Risk Factors Arm

Diagnostic Test: Standard Screening Arm

Interventions

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.

Also known as: Lung Cancer Risk Prediction Model Arm

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.

Also known as: Traditional High-Risk Factors Arm

Standard Screening Arm

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Central Study Contacts

Wenhua Liang professor, doctor

CONTACT

+86 020-83062808; liangwh1987@163.com

Huiting Wang

CONTACT

+86 15622132598; wangh1805657064@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share