NCT04938804

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,000

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
7mo left

Started Dec 2015

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Dec 2015Dec 2026

Study Start

First participant enrolled

December 12, 2015

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

10 years

First QC Date

June 12, 2021

Last Update Submit

January 7, 2024

Conditions

Keywords

Screening

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Detection rates of lung cancer and the proportion of stage I lung cancer cases between "high-risk" and "non-high-risk" groups

    11 years

  • Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments)

    11 years

Study Arms (1)

Screening group

EXPERIMENTAL
Device: Low-dose computed tomography

Interventions

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

Screening group

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum age of 40 years among the residents in Guangzhou

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

  • Ye W, Fu W, Li C, Li J, Xiong S, Cheng B, Xu B, Wang Q, Feng Y, Chen P, He J, Liang W. Diameter thresholds for pure ground-glass pulmonary nodules at low-dose CT screening: Chinese experience. Thorax. 2025 Jan 17;80(2):76-85. doi: 10.1136/thorax-2024-221642.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Wenhua Liang, MD

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhua Liang, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2021

First Posted

June 24, 2021

Study Start

December 12, 2015

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations