China Lung Cancer Screening (CLUS) Study Version 3.0

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Other: Whole-process management software; Device: LDCT detection

• Registration Number: NCT05494021
• Lead Sponsor: Shanghai Chest Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-07
• Study First Submitted QC: 2022-08-07
• Last Update Submitted: 2022-08-07
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

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

• Had a CT scan of chest within last 12 months
• History of any cancer within 5 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole-process management strategy	Whole-process management software	High-risk individuls are provided with whole-process management strategy, including 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. LDCT was performed at baseline + 2 biennial repeated LDCT rounds.
Rountine screening strategy	LDCT detection	LDCT was performed at baseline + 2 biennial repeated LDCT rounds.
Whole-process management strategy	LDCT detection	High-risk individuls are provided with whole-process management strategy, including 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. LDCT was performed at baseline + 2 biennial repeated LDCT rounds.

Primary Outcome Measures

Name	Time	Method
The attendance rate of high-risk individuals	5 years	Evaluate the ability of whole-process management strategy in enhancing the attendance rate of high-risk individuals
The mortality rate of lung cancer	5 years	Assess lung cancer mortality within next 5 years after first round of screening
The adherence rate of high-risk individuals	5 years	Evaluate the ability of whole-process management strategy in enhancing the adherence rate of high-risk individuals

Secondary Outcome Measures

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