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China Lung Cancer Screening (CLUS) Study Version 2.0

Primary Purpose

Lung Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low Dose Computed Tomography
artificial intelligence (AI)
autofluorescence imaging (AFI)
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Neoplasms

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shanghai Chest hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LDCT Screening

Arm Description

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 AI in enhancing the attendance rate of high-risk individuals
Diagnostic accuracy rate of lung cancer
Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer

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

First Posted
June 4, 2019
Last Updated
May 27, 2022
Sponsor
Shanghai Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03975504
Brief Title
China Lung Cancer Screening (CLUS) Study Version 2.0
Official Title
Community-based Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 2.0
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LDCT Screening
Arm Type
Other
Arm Description
LDCT was performed at baseline + 2 biennial repeated LDCT rounds
Intervention Type
Device
Intervention Name(s)
Low Dose Computed Tomography
Intervention Description
LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm
Intervention Type
Device
Intervention Name(s)
artificial intelligence (AI)
Intervention Description
AI was performed in high-risk individuals recruitment and lung nodules management
Intervention Type
Diagnostic Test
Intervention Name(s)
autofluorescence imaging (AFI)
Intervention Description
AFI applied in screening of centrally located SCC.
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 AI in enhancing the attendance rate of high-risk individuals
Time Frame
5 year
Title
Diagnostic accuracy rate of lung cancer
Description
Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer
Time Frame
5 year
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 year
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baohui Han, MD Dr.
Phone
8618930858216
Email
18930858216@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanwei Zhang, MD Dr.
Phone
8618930599895
Email
zhangyw198691@163.com
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
Phone
8618930858216
Ext
8618930858216
Email
18930858216@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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China Lung Cancer Screening (CLUS) Study Version 2.0

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