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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

Tracking Information
First Submitted Date  ICMJE June 12, 2021
First Posted Date  ICMJE June 24, 2021
Last Update Posted Date June 24, 2021
Actual Study Start Date  ICMJE December 1, 2015
Estimated Primary Completion Date December 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2021)
The incidence of lung cancer [ Time Frame: 11 years ]
The incidence of lung cancer among the overall people in the screening
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2021)
  • 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
  • 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
  • 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
  • Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments) [ Time Frame: 11 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mass Screening With Low-Dose CT for Lung Cancer in Guangzhou
Official Title  ICMJE Mass Screening With Low-Dose CT for Lung Cancer in Guangzhou
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Lung Cancer
Intervention  ICMJE Device: Low-dose computed tomography
The Low-dose computed tomography is conducted according to the guideline suggested by American College of Radiology.
Study Arms  ICMJE Experimental: Screening group
Intervention: Device: Low-dose computed tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2021)
11000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2026
Estimated Primary Completion Date December 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Wenhua Liang, MD +86-02-83062808 liangwh1987@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04938804
Other Study ID Numbers  ICMJE GZLUNG
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
Study Sponsor  ICMJE The First Affiliated Hospital of Guangzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wenhua Liang, MD The First Affiliated Hospital of Guangzhou Medical University
PRS Account The First Affiliated Hospital of Guangzhou Medical University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP