China Lung Cancer Screening (CLUS) Study Version 3.0

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Lung Cancer

Treatments: Device: LDCT detection; Other: Whole-process management software

Study type: Interventional

Funder types: Other

Identifiers

NCT05494021

CLUS 3.0

Details and patient eligibility

About

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.

Enrollment: 100,000 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100,000 participants in 2 patient groups

Whole-process management strategy

Experimental group

Description:

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.

Treatment:

Device: LDCT detection

Other: Whole-process management software

Rountine screening strategy

Active Comparator group

Description:

LDCT was performed at baseline + 2 biennial repeated LDCT rounds.

Treatment:

Device: LDCT detection