NCT05494021

China Lung Cancer Screening (CLUS) Study Version 3.0

Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 3.0

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100,000 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

CLUS version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). CLUS version 2.0 evaluated the efficacy of new techniques (AI, AFI and MTB) in fostering the implementation of lung cancer screening (NCT03975504). The present multi-center study is performed to evaluate the effectiveness of different lung cancer screening strategy and validate our previous findings. 100,000 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 Cancer

Interventions

Type	Name	Description
OTHER	Whole-process management software	Enrolled participants will managed by a pre-designed software. The software would provide helpful assistance, such as lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer.
DEVICE	LDCT detection	LDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm

Timeline

• Start date: 2022-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-08-09
• Last updated: 2022-08-09

Locations

1 site across 1 country: China