The present study is a single arm clinical trial aiming to improve the key technology in the diagnosis and treatment of early stage lung cancer. 60,000 high-risk subjects (age 45-70) are planned to recruit and assign to the Low Dose Computed Tomography (LDCT) screening arm (Baseline + 2 rounds of biennial repeated LDCT screening). Management of positive screening test will be carried out by a pre-specified protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60,000
LDCT was performed at baseline and 2 rounds of biennial repeated LDCT. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm. The management of abnormal nodules including precision diagnosis by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), electromagnetic navigation bronchoscope (ENB) and peripheral biomarkers, and precision therapy by intraoperative frozen section guided lung resection and ENB radiofrequency ablation.
Shanghai Chest hospital
Shanghai, Shanghai Municipality, China
Lung cancer incidence rate
Assess the number of lung cancer incidences after each round of screening. Compared the stage differences between screening arm and natural incidence.
Time frame: 5 years
Lung cancer disease free survival
Compared the disease-free survival (DFS) among different treatment strategy of early stage lung cancer.
Time frame: 5 years
Lung cancer mortality
Assess lung cancer mortality within next 5 years after first round of screening
Time frame: 5 years
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