Early Stage Lung Cancer Screening With Low-dose Computed Tomographic

Not Applicable

• Conditions: Lung Cancer
• Interventions: Device: Low Dose Computed Tomography

• Registration Number: NCT02898441
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2016-09
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-08
• Last Update Submitted: 2016-09-08
• Study First Posted: 2016-09-13
• Last Update Posted: 2016-09-13
• Primary Completion: 2016-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screening Arm	Low Dose Computed Tomography	LDCT was performed at baseline + 2 biennial repeated LDCT rounds

Primary Outcome Measures

Name	Time	Method
Lung cancer incidence rate	5 years	Assess the number of lung cancer incidences after each round of screening in both arms. Compared the stage differences between screening arm and usual care arm.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	5 years	Assess all-cause mortality in both arms within next 5 years after first round of screening.
Lung cancer mortality	5 years	Assess lung cancer mortality in both arms within next 5 years after first round of screening.

Trial Locations

Locations (1)

Shanghai Chest hospital; 🇨🇳 Shanghai, Shanghai, China