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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938804
• Other study ID #: GZLUNG
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2015
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Wenhua Liang, MD
• Phone: +86-02-83062808
• Email: liangwh1987[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11000
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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).

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Low-dose computed tomography
The Low-dose computed tomography is conducted according to the guideline suggested by American College of Radiology.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The detection rate of lung cancer	Lung cancer detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases.	11 years
Primary	To investigate the various factors associated with the development of lung cancer	To investigate the various factors associated with the development of lung cancer	11 years
Secondary	Detection rates of lung cancer and the proportion of stage I lung cancer cases between "high-risk" and "non-high-risk" groups	The detection rate of lung cancer among people with "high-risk" and "non-high-risk"factors	11 years
Secondary	Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments)		11 years