Lung Cancer
Conditions
Keywords
early stage lung cancer, LDCT screening, lung resection, electromagnetic navigation bronchoscopy, peripheral biomarker
Brief summary
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.
Interventions
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.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
• Eligible participants were those aged 45-70 years, and with either of the following risk factors: 1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years; 2. malignant tumors history in immediate family members; 3. personal cancer history; 4. professional exposure to carcinogens; 5. long term exposure to second-hand smoke; 6. long term exposure to cooking oil fumes.
Exclusion criteria
1. Had a CT scan of chest within last 12 months 2. History of any cancer within 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung cancer incidence rate | 5 years | Assess the number of lung cancer incidences after each round of screening. Compared the stage differences between screening arm and natural incidence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung cancer disease free survival | 5 years | Compared the disease-free survival (DFS) among different treatment strategy of early stage lung cancer. |
| Lung cancer mortality | 5 years | Assess lung cancer mortality within next 5 years after first round of screening |
Countries
China
Contacts
Primary ContactBaohui Han, MD, PhD
Backup ContactYanwei Zhang, MD, PhD
Outcome results
None listed