Lung Neoplasms
Conditions
Brief summary
Our previous study, china lung cancer screening study version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). The present one arm study is performed to evaluate the efficacy of new techniques in improving the implementation of lung cancer screening and validate our previous findings. 6000 high-risk subjects (age 45-75) were recruited to take LDCT screening. (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored 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 5 mm
DEVICEartificial intelligence (AI)
AI was performed in high-risk individuals recruitment and lung nodules management
DIAGNOSTIC_TESTautofluorescence imaging (AFI)
AFI applied in screening of centrally located SCC.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Eligible participants were those aged 45-75 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 |
|---|---|---|
| The mortality rate of lung cancer | 5 years | Assess lung cancer mortality within next 5 years after first round of screening |
| The attendance rate of high-risk individuals | 5 year | Evaluate the ability of AI in enhancing the attendance rate of high-risk individuals |
| Diagnostic accuracy rate of lung cancer | 5 year | Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The mortality of all-cause | 5 years | Assess all-cause mortality within next 5 years after first round of screening |
| The detection rate of lung nodules | 5 year | Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening |
| The incidence rate lung cancer | 5 years | Assess the number of lung cancer incidences after each round of screening |
Countries
China
Contacts
Primary ContactBaohui Han, MD Dr.
Backup ContactYanwei Zhang, MD Dr.
Outcome results
None listed