NCT03975504

China Lung Cancer Screening (CLUS) Study Version 2.0

Community-based Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 2.0

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-08-01
• Primary completion: 2023-06-30
• Completion: 2023-07-31
• First posted: 2019-06-05
• Last updated: 2022-06-01

Locations

1 site across 1 country: China