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China Lung Cancer Screening (CLUS) Study Version 2.0

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ClinicalTrials.gov Identifier: NCT03975504
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Baohui Han, Shanghai Chest Hospital

Brief Summary:
Our previous study 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 validate our previous findings and optimize the screening procedure. 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
Lung Neoplasms Device: Low Dose Computed Tomography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
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 : August 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Lung cancer incidence rate [ Time Frame: 5 years ]
    Assess the number of lung cancer incidences after each round of screening

  2. Lung cancer mortality [ Time Frame: 5 years ]
    Assess lung cancer mortality within next 5 years after first round of screening


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 5 years ]
    Assess all-cause mortality within next 5 years after first round of screening

  2. Nodule detection rate [ Time Frame: 1 year ]
    Assess nodule detection rate, and the types and sizes of nodules detected in LDCT screening arm



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975504


Contacts
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Contact: Baohui Han, MD Dr. 8618930858216 18930858216@163.com
Contact: Yanwei Zhang, MD Dr. 8618930599895 zhangyw198691@163.com

Locations
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China, Shanghai
Shanghai Chest hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Baohui Han    8618930858216 ext 8618930858216    18930858216@163.com   
Sponsors and Collaborators
Shanghai Chest Hospital

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Responsible Party: Baohui Han, Director, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT03975504     History of Changes
Other Study ID Numbers: CHEST1809
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases