Not yet recruiting NCT07078032
A Randomized Controlled Trial Evaluating the Effectiveness of a Novel Risk-Stratified Screening Strategy for Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prediction Model Arm, Standard Screening Arm.
- Who it may be relevant to
- Registry conditions: Lung Cancer Screening. Basic parameters: 40 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Prediction Model Arm
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. - Diagnostic test Standard Screening Arm
Participants are screened based on NCCN guideline criteria. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases.
Primary outcome measures
- Positive Predictive Value (PPV) of Screening Strategies [Time frame: From enrollment through completion of diagnostic confirmation (up to 3 months post-screening)]
Secondary outcome measures (6)
- Sensitivity of Screening Strategies [Time frame: From screening to 12-month follow-up]
- Specificity of Screening Strategies [Time frame: From screening to 12-month follow-up]
- Negative Predictive Value (NPV) [Time frame: From screening to 12-month follow-up]
- Early-Stage Shift Proportion [Time frame: At time of cancer diagnosis (within 3 months post-positive screening)]
- Lung Cancer-Specific Mortality Rate [Time frame: From randomization to 3-year follow-up]
- Overall Survival in Screen-Detected Lung Cancer [Time frame: From cancer diagnosis to 3-year follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07078032 · 20250711