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Recruiting NCT04938804

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

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-dose computed tomography.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 40 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • The detection rate of lung cancer [Time frame: 11 years]
  • To investigate the various factors associated with the development of lung cancer [Time frame: 11 years]
Secondary outcome measures (2)
  • 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]
  • Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments) [Time frame: 11 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

China · 1 center
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou

Publications

  • 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. PMID 39689940

Identifiers

NCT: NCT04938804 · GZLUNG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗