China Lung Cancer Screening (CLUS) Study Version 2.0

Not Applicable

• Conditions: Lung Neoplasms
• Interventions: Device: Low Dose Computed Tomography; Device: artificial intelligence (AI); Diagnostic Test: autofluorescence imaging (AFI)

• Registration Number: NCT03975504
• Lead Sponsor: Shanghai Chest Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-05
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-06-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

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.

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Exclusion Criteria

1. Had a CT scan of chest within last 12 months
2. History of any cancer within 5 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LDCT Screening	artificial intelligence (AI)	LDCT was performed at baseline + 2 biennial repeated LDCT rounds
LDCT Screening	autofluorescence imaging (AFI)	LDCT was performed at baseline + 2 biennial repeated LDCT rounds
LDCT Screening	Low Dose Computed Tomography	LDCT was performed at baseline + 2 biennial repeated LDCT rounds

Primary Outcome Measures

Name	Time	Method
The mortality rate of lung cancer	5 years	Assess lung cancer mortality within next 5 years after first round of screening
The attendance rate of high-risk individuals	5 year	Evaluate the ability of AI in enhancing the attendance rate of high-risk individuals
Diagnostic accuracy rate of lung cancer	5 year	Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer

Secondary Outcome Measures

Name	Time	Method
The detection rate of lung nodules	5 year	Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening
The mortality of all-cause	5 years	Assess all-cause mortality within next 5 years after first round of screening
The incidence rate lung cancer	5 years	Assess the number of lung cancer incidences after each round of screening

Trial Locations

Locations (1)

Shanghai Chest hospital; 🇨🇳 Shanghai, Shanghai, China