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Mass Screening With Low-Dose CT for Lung Cancer in Guangzhou

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ClinicalTrials.gov Identifier: NCT04938804
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

Brief Summary:
A single-arm, prospective study to explore the incidence of lung cancer, the high-risk factor of lung cancer, and the cost-effectiveness of early screening of lung cancer in the general population over 40 years old with low-dose computed tomography in Guangzhou, China

Condition or disease Intervention/treatment Phase
Lung Cancer Device: Low-dose computed tomography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Mass Screening With Low-Dose CT for Lung Cancer in Guangzhou
Actual Study Start Date : December 1, 2015
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Screening group Device: Low-dose computed tomography
The Low-dose computed tomography is conducted according to the guideline suggested by American College of Radiology.




Primary Outcome Measures :
  1. The incidence of lung cancer [ Time Frame: 11 years ]
    The incidence of lung cancer among the overall people in the screening


Secondary Outcome Measures :
  1. The incidence of lung cancer among people with high-risk factors [ Time Frame: 11 years ]
    The incidence of lung cancer among people with high-risk factors

  2. The incidence of lung cancer among people with non-high-risk factors [ Time Frame: 11 years ]
    The incidence of lung cancer among people with non-high-risk factors

  3. High risk factors associated with lung cancer (by questionnaire) [ Time Frame: 11 years ]
    Every participant has to complete a questionnaire before undergoing an LDCT examination. Univariate analysis and multivariate logistic regression analyses will be performed to determine the high risk factors associated with lung cancer

  4. Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments) [ Time Frame: 11 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Minimum age of 40 years among the residents in Guangzhou

Exclusion Criteria:

  • Persons who had a diagnosis of lung cancer or treatment-related to lung cancer with the past 5 years, had a diagnosis of any other cancer within the past 5 years (except for nonmelanoma skin cancer)
  • Had hemoptysis
  • Had an unexplained weight loss of more than 6.8 kg in the previous year
  • Had a CT scan of chest within the previous year

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): NCT04938804


Contacts
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Contact: Wenhua Liang, MD +86-02-83062808 liangwh1987@163.com

Locations
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China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Wenhua Liang, MD    +86-02-83062808    liangwh1987@163.com   
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
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Principal Investigator: Wenhua Liang, MD The First Affiliated Hospital of Guangzhou Medical University
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Responsible Party: Jianxing He, Professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT04938804    
Other Study ID Numbers: GZLUNG
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianxing He, The First Affiliated Hospital of Guangzhou Medical University:
Screening
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases