China Lung Cancer Screening (CLUS) Study Version 2.0

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03975504
• Other study ID #: CHEST1809
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: July 31, 2023

Study information

• Verified date: May 2022
• Source: Shanghai Chest Hospital
• Contact: Baohui Han, MD Dr.
• Phone: 8618930858216
• Email: 18930858216[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• 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:

1. Had a CT scan of chest within last 12 months

2. History of any cancer within 5 years

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Device:
• Low Dose Computed Tomography
LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm
• 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.

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 AI in enhancing the attendance rate of high-risk individuals	5 year
Primary	Diagnostic accuracy rate of lung cancer	Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer	5 year
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 year
Secondary	The incidence rate lung cancer	Assess the number of lung cancer incidences after each round of screening	5 years