Lung Cancer
Conditions
Keywords
lung cancer screening, low-dose CT, high-risk population
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.
Interventions
LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
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 in both arms. Compared the stage differences between screening arm and usual care arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung cancer mortality | 5 years | Assess lung cancer mortality in both arms within next 5 years after first round of screening. |
| All-cause mortality | 5 years | Assess all-cause mortality in both arms within next 5 years after first round of screening. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nodule detection rate | One year | Assess nodule detection rate, and the types and sizes of nodules detected in LDCT screening arm. |
Countries
China
Contacts
Primary ContactBaohui Han, MD, PhD
Backup ContactYanwei Zhang, MD, PhD
Outcome results
None listed