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Early Stage Lung Cancer Screening With Low-dose Computed Tomographic

Not Applicable
Conditions
Lung Cancer
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

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
Primary Outcome Measures
NameTimeMethod
Lung cancer incidence rate5 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
NameTimeMethod
All-cause mortality5 years

Assess all-cause mortality in both arms within next 5 years after first round of screening.

Lung cancer mortality5 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

Shanghai Chest hospital
🇨🇳Shanghai, Shanghai, China
Baohui Han, MD,PhD
Contact
86-21-62821990
xkyyhan@gmail.com
Yanwei Zhang, MD,PhD
Contact
86-15216687683
zhangyw198691@163.com

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