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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

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