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Trial Title:
China Lung Cancer Screening (CLUS) Study Version 3.0
NCT ID:
NCT05494021
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Whole-process management software
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.
Arm group label:
Whole-process management strategy
Intervention type:
Device
Intervention name:
LDCT detection
Description:
LDCT were performed in both arm. The abnormal nodules were defined as noncalcified
nodules (NCN) larger than 5 mm
Arm group label:
Rountine screening strategy
Arm group label:
Whole-process management strategy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Eligible participants were those aged 45-75 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:
- Had a CT scan of chest within last 12 months
- History of any cancer within 5 years
Gender:
All
Minimum age:
45 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Shanghai Chest hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Baohui Han, Doctor
Phone:
8618930858216
Email:
18930858216@163.com
Contact backup:
Last name:
Yanwei Zhang, Doctor
Phone:
+8615216687683
Email:
zhangywshxkyy@163.com
Start date:
January 1, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05494021