China Lung Cancer Screening (CLUS) Study Version 3.0

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494021
• Other study ID #: CLUS 3.0
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2022
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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:

• Had a CT scan of chest within last 12 months

• History of any cancer within 5 years

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Chest hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mortality rate of lung cancer	Assess lung cancer mortality within next 5 years after first round of screening	5 years
Primary	The attendance rate of high-risk individuals	Evaluate the ability of whole-process management strategy in enhancing the attendance rate of high-risk individuals	5 years
Primary	The adherence rate of high-risk individuals	Evaluate the ability of whole-process management strategy in enhancing the adherence rate of high-risk individuals	5 years
Secondary	The mortality of all-cause	Assess all-cause mortality within next 5 years after first round of screening	5 years
Secondary	The detection rate of lung nodules	Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening	5 years
Secondary	The incidence rate lung cancer	Assess the number of lung cancer incidences after each round of screening	5 years