China Lung Cancer Screening (CLUS) Study Version 2.0

Shanghai Jiao Tong University

Status: Unknown

Conditions: Lung Neoplasms

Treatments: Diagnostic Test: autofluorescence imaging (AFI); Device: Low Dose Computed Tomography; Device: artificial intelligence (AI)

Study type: Interventional

Funder types: Other

Identifiers

NCT03975504

CHEST1809

Details and patient eligibility

About

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.

Enrollment: 6,000 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

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6,000 participants in 1 patient group

LDCT Screening

Other group

Description:

LDCT was performed at baseline + 2 biennial repeated LDCT rounds

Treatment:

Diagnostic Test: autofluorescence imaging (AFI)

Device: artificial intelligence (AI)

Device: Low Dose Computed Tomography