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NCT Number: NCT05494021

China Lung Cancer Screening (CLUS) Study Version 3.0

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible participants were those aged 45-75 years, and with either of the following risk factors:
  • history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
  • malignant tumors history in immediate family members;
  • personal cancer history;
  • professional exposure to carcinogens;
  • long term exposure to second-hand smoke;
  • 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

Treatment and study plan

Whole-process management software

Other

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.

LDCT detection

Device

LDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm

Primary outcomes

  1. The mortality rate of lung cancer

    Time frame: 5 years

    Assess lung cancer mortality within next 5 years after first round of screening

  2. The attendance rate of high-risk individuals

    Time frame: 5 years

    Evaluate the ability of whole-process management strategy in enhancing the attendance rate of high-risk individuals

  3. The adherence rate of high-risk individuals

    Time frame: 5 years

    Evaluate the ability of whole-process management strategy in enhancing the adherence rate of high-risk individuals

Secondary outcomes

  1. The mortality of all-cause

    Time frame: 5 years

    Assess all-cause mortality within next 5 years after first round of screening

  2. The detection rate of lung nodules

    Time frame: 5 years

    Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening

  3. The incidence rate lung cancer

    Time frame: 5 years

    Assess the number of lung cancer incidences after each round of screening

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2022
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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