China Lung Cancer Screening (CLUS) Study Version 2.0

Community-based Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 2.0

Our previous study, china lung cancer screening study version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). The present one arm study is performed to evaluate the efficacy of new techniques in improving the implementation of lung cancer screening and validate our previous findings. 6000 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.

Study Overview

• Status: Recruiting
• Conditions: Lung Neoplasms
• Intervention / Treatment: Device: Low Dose Computed Tomography; Device: artificial intelligence (AI); Diagnostic test: autofluorescence imaging (AFI)

• Study Type: Interventional
• Enrollment (Anticipated): 6000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Baohui Han, MD Dr.; Phone Number: 8618930858216; Email: 18930858216@163.com
• Study Contact Backup: Name: Yanwei Zhang, MD Dr.; Phone Number: 8618930599895; Email: zhangyw198691@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Baohui Han; Phone Number: 8618930858216 8618930858216; Email: 18930858216@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Had a CT scan of chest within last 12 months
2. History of any cancer within 5 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LDCT Screening; LDCT was performed at baseline + 2 biennial repeated LDCT rounds	Device: Low Dose Computed Tomography; LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm; Device: artificial intelligence (AI); AI was performed in high-risk individuals recruitment and lung nodules management; Diagnostic test: autofluorescence imaging (AFI); AFI applied in screening of centrally located SCC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mortality rate of lung cancer	Assess lung cancer mortality within next 5 years after first round of screening	5 years
The attendance rate of high-risk individuals	Evaluate the ability of AI in enhancing the attendance rate of high-risk individuals	5 year
Diagnostic accuracy rate of lung cancer	Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer	5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mortality of all-cause	Assess all-cause mortality within next 5 years after first round of screening	5 years
The detection rate of lung nodules	Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening	5 year
The incidence rate lung cancer	Assess the number of lung cancer incidences after each round of screening	5 years

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CHEST1809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No