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

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Device: Low-dose computed tomography

• Registration Number: NCT04938804
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2015-12-12
• Study First Submitted: 2021-06-12
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-07
• Last Update Posted: 2024-01-09
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 11000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening group	Low-dose computed tomography	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China