Community-based Early Stage Lung Cancer Screening With Low-dose Computed Tomography in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 6000
- Locations
- 1
- Primary Endpoint
- Lung cancer incidence rate
- Last Updated
- 9 years ago
Overview
Brief Summary
The present study is a randomized controlled trial of LDCT screening for lung cancer versus usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored from the Active arm in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.
Investigators
Baohui Han
Vice-President
Shanghai Chest Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Lung cancer incidence rate
Time Frame: 5 years
Assess the number of lung cancer incidences after each round of screening in both arms. Compared the stage differences between screening arm and usual care arm.
Secondary Outcomes
- All-cause mortality(5 years)
- Lung cancer mortality(5 years)