Early Stage Lung Cancer Screening With Low-dose Computed Tomographic
Community-based Early Stage Lung Cancer Screening With Low-dose Computed Tomography in China
1 other identifier
interventional
6,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Jan 2014
Longer than P75 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 8, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedSeptember 13, 2016
September 1, 2016
2.9 years
September 8, 2016
September 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lung cancer incidence rate
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.
5 years
Secondary Outcomes (2)
Lung cancer mortality
5 years
All-cause mortality
5 years
Other Outcomes (1)
Nodule detection rate
One year
Study Arms (2)
Screening Arm
ACTIVE COMPARATORLDCT was performed at baseline + 2 biennial repeated LDCT rounds
Passive Arm
NO INTERVENTIONEligible subjects were randomized to follow up in usual care
Interventions
LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm.
Eligibility Criteria
You may qualify if:
- Eligible participants were those aged 45-70 years, and with either of the following risk factors:
- history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
- malignant tumors history in immediate family members;
- personal cancer history;
- professional exposure to carcinogens;
- long term exposure to second-hand smoke;
- long term exposure to cooking oil fumes.
You may not qualify if:
- Had a CT scan of chest within last 12 months
- History of any cancer within 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Chest hospital
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baohui Han, MD, PhD
Shanghai Chest Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice-President
Study Record Dates
First Submitted
September 8, 2016
First Posted
September 13, 2016
Study Start
January 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2018
Last Updated
September 13, 2016
Record last verified: 2016-09