Back to resultsChina Lung Cancer Screening (CLUS) Study Version 3.0
Primary Purpose
Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Whole-process management software
LDCT detection
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
Eligible participants were those aged 45-75 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.
Exclusion Criteria:
- Had a CT scan of chest within last 12 months
- History of any cancer within 5 years
Sites / Locations
- Shanghai Chest hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Whole-process management strategy
Rountine screening strategy
Arm Description
High-risk individuls are provided with whole-process management strategy, including lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer. LDCT was performed at baseline + 2 biennial repeated LDCT rounds.
LDCT was performed at baseline + 2 biennial repeated LDCT rounds.
Outcomes
Primary Outcome Measures
The mortality rate of lung cancer
Assess lung cancer mortality within next 5 years after first round of screening
The attendance rate of high-risk individuals
Evaluate the ability of whole-process management strategy in enhancing the attendance rate of high-risk individuals
The adherence rate of high-risk individuals
Evaluate the ability of whole-process management strategy in enhancing the adherence rate of high-risk individuals
Secondary Outcome Measures
The mortality of all-cause
Assess all-cause mortality within next 5 years after first round of screening
The detection rate of lung nodules
Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening
The incidence rate lung cancer
Assess the number of lung cancer incidences after each round of screening
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05494021
Brief Title
China Lung Cancer Screening (CLUS) Study Version 3.0
Official Title
Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 3.0
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
CLUS version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). CLUS version 2.0 evaluated the efficacy of new techniques (AI, AFI and MTB) in fostering the implementation of lung cancer screening (NCT03975504). The present multi-center study is performed to evaluate the effectiveness of different lung cancer screening strategy and validate our previous findings. 100,000 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Whole-process management strategy
Arm Type
Experimental
Arm Description
High-risk individuls are provided with whole-process management strategy, including lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer.
LDCT was performed at baseline + 2 biennial repeated LDCT rounds.
Arm Title
Rountine screening strategy
Arm Type
Active Comparator
Arm Description
LDCT was performed at baseline + 2 biennial repeated LDCT rounds.
Intervention Type
Other
Intervention Name(s)
Whole-process management software
Intervention Description
Enrolled participants will managed by a pre-designed software. The software would provide helpful assistance, such as lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer.
Intervention Type
Device
Intervention Name(s)
LDCT detection
Intervention Description
LDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm
Primary Outcome Measure Information:
Title
The mortality rate of lung cancer
Description
Assess lung cancer mortality within next 5 years after first round of screening
Time Frame
5 years
Title
The attendance rate of high-risk individuals
Description
Evaluate the ability of whole-process management strategy in enhancing the attendance rate of high-risk individuals
Time Frame
5 years
Title
The adherence rate of high-risk individuals
Description
Evaluate the ability of whole-process management strategy in enhancing the adherence rate of high-risk individuals
Time Frame
5 years
Secondary Outcome Measure Information:
Title
The mortality of all-cause
Description
Assess all-cause mortality within next 5 years after first round of screening
Time Frame
5 years
Title
The detection rate of lung nodules
Description
Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening
Time Frame
5 years
Title
The incidence rate lung cancer
Description
Assess the number of lung cancer incidences after each round of screening
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Eligible participants were those aged 45-75 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.
Exclusion Criteria:
Had a CT scan of chest within last 12 months
History of any cancer within 5 years
Facility Information:
Facility Name
Shanghai Chest hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baohui Han, Doctor
Phone
8618930858216
Email
18930858216@163.com
First Name & Middle Initial & Last Name & Degree
Yanwei Zhang, Doctor
Phone
+8615216687683
Email
zhangywshxkyy@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
China Lung Cancer Screening (CLUS) Study Version 3.0
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