Non-risk Based Lang Cancer Screening With a One-off LDCT

January 7, 2024 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

Non-risk Based Lung Cancer Screening With One-time Low-dose Computed Tomography: a Prospective Cohort Study

Guangzhou Lung-Care Project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of LC, recruiting residents aged 40-74 years from four communities in Guangzhou between 2015 and 2021.The primary outcome was LC detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases, and to investigate the various factors associated with the development of LC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Guangzhou Lung-Care Project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of LC, recruiting residents aged 40-74 years from four communities in Guangzhou between 2015 and 2021. Follow-up for post-screening management and survival was recorded. The primary outcome was LC detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases, and to investigate the various factors associated with the development of LC. Additionally, we compared the detection rates of LC and the proportion of stage I LC cases between "high-risk" and "non-high-risk" groups according to the National Comprehensive Cancer Network (NCCN) guidelines and Chinese guideline.

Study Type

Interventional

Enrollment (Estimated)

11000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Minimum age of 40 years among the residents in Guangzhou

Exclusion Criteria:

  • Persons who had a diagnosis or treatment related to LC within the past 5 years, had undergone chest CT within the past year, or had significant cancer-related symptoms (e.g., hemoptysis, dyspnea, inability to climb two flights of stairs).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The detection rate of lung cancer
Time Frame: 11 years
Lung cancer detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases.
11 years
To investigate the various factors associated with the development of lung cancer
Time Frame: 11 years
To investigate the various factors associated with the development of lung cancer
11 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments)
Time Frame: 11 years
11 years
Detection rates of lung cancer and the proportion of stage I lung cancer cases between "high-risk" and "non-high-risk" groups
Time Frame: 11 years
The detection rate of lung cancer among people with "high-risk" and "non-high-risk"factors
11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Investigators

  • Principal Investigator: Wenhua Liang, MD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2015

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 12, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZLUNG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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