China Lung Cancer Screening (CLUS) Study Version 2.0

Sponsor
Shanghai Chest Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03975504
Collaborator
(none)
6,000
1
1
60
100.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Low Dose Computed Tomography
  • Device: artificial intelligence (AI)
  • Diagnostic Test: autofluorescence imaging (AFI)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Community-based Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 2.0
Actual Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The mortality rate of lung cancer [5 years]

    Assess lung cancer mortality within next 5 years after first round of screening

  2. The attendance rate of high-risk individuals [5 year]

    Evaluate the ability of AI in enhancing the attendance rate of high-risk individuals

  3. Diagnostic accuracy rate of lung cancer [5 year]

    Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer

Secondary Outcome Measures

  1. The mortality of all-cause [5 years]

    Assess all-cause mortality within next 5 years after first round of screening

  2. The detection rate of lung nodules [5 year]

    Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening

  3. The incidence rate lung cancer [5 years]

    Assess the number of lung cancer incidences after each round of screening

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Chest hospital Shanghai Shanghai China 200030

Sponsors and Collaborators

  • Shanghai Chest Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Baohui Han, Director, Shanghai Chest Hospital
ClinicalTrials.gov Identifier:
NCT03975504
Other Study ID Numbers:
  • CHEST1809
First Posted:
Jun 5, 2019
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022