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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2028-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Lung Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Prediction Model Arm

Lung Cancer Risk Prediction Model Arm

Group Type EXPERIMENTAL

Prediction Model Arm

Intervention Type 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

Traditional High-Risk Factors Arm

Group Type ACTIVE_COMPARATOR

Standard Screening Arm

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Lung Cancer Risk Prediction Model Arm Traditional High-Risk Factors Arm

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes