China Lung Cancer Screening (CLUS) Study Version 2.0
NCT03975504 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000
Last updated 2022-06-01
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.
Conditions
- Lung Neoplasms
Interventions
- DEVICE
-
Low Dose Computed Tomography
LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm
- DEVICE
-
artificial intelligence (AI)
AI was performed in high-risk individuals recruitment and lung nodules management
- DIAGNOSTIC_TEST
-
autofluorescence imaging (AFI)
AFI applied in screening of centrally located SCC.
Sponsors & Collaborators
-
Shanghai Chest Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-08-01
- Primary Completion
- 2023-06-30
- Completion
- 2023-07-31
Countries
- China
Study Locations
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