Early Stage Lung Cancer Screening With Low-dose Computed Tomographic

Shanghai Jiao Tong University

Status: Unknown

Conditions: Lung Cancer

Treatments: Device: Low Dose Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT02898441

2013ZYJB0402

Details and patient eligibility

About

The present study is a randomized controlled trial of LDCT screening for lung cancer versus usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored from the Active arm 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 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Eligible participants were those aged 45-70 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,000 participants in 2 patient groups

Screening Arm

Active Comparator group

Description:

LDCT was performed at baseline + 2 biennial repeated LDCT rounds

Treatment:

Device: Low Dose Computed Tomography

Passive Arm

No Intervention group

Description:

Eligible subjects were randomized to follow up in usual care