Precision Diagnosis and Therapy for Early Stage Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Key Technology in Precision Diagnosis and Therapy for Early Stage Lung Cancer: a Single Arm Clinical Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Low Dose Computed Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Eligible participants were those aged 45-70 years, and with either of the following risk factors: history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years; malignant tumors history in immediate family members; personal cancer history; professional exposure to carcinogens; long term exposure to second-hand smoke; long term exposure to cooking oil fumes. Exclusion Criteria: Had a CT scan of chest within last 12 months History of any cancer within 5 years

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening Arm<br>Low Dose Computed Tomography (LDCT) was performed at baseline + 2 rounds of biennial repeated LDCT. Management of positive screening test will be carried out by a pre-specified protocol. | Device: Low Dose Computed Tomography<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung cancer disease free survival | Compared the disease-free survival (DFS) among different treatment strategy of early stage lung cancer. | 5 years | 
| Lung cancer mortality | Assess lung cancer mortality within next 5 years after first round of screening | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early stage lung cancer, LDCT screening, lung resection, electromagnetic navigation bronchoscopy, peripheral biomarker