An interventional study of Low-dose CT screening and AI full-lung model interpretation system in Respiratory Tract Neoplasms, Thoracic Neoplasms and Neoplasms by Site, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Recruiting at 1 site in China. Open to participants aged 40 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Screening
Low-dose CT (LDCT）can detect and treat lung cancer earlier and more quickly, while expanded screening coverage helps reduce the incidence and mortality of respiratory diseases such as lung cancer. This study aims to conduct a single-arm cluster randomized trial of digitally enabled LDCT in Guangzhou to assess its intervention effectiveness and cost-effectiveness.
This study uses a single-arm design to assign community health service centers in two districts of Guangzhou (Liwan and Baiyun) to the intervention group. A historical self-comparison design is employed. The intervention measures utilize a digital empowerment model for lung cancer screening, which includes the following components: ① Digital health platform: Each street and community health center manages resident information through the Lung Health mini-program; ② AI-based full-lung model reading system: Using artificial intelligence technology to assist in interpreting CT images; ③ Low-dose CT screening: Low-dose CT screening is conducted at primary healthcare institutions, and patients with detected lung nodules are referred to hospitals for further examination. The sampling method used is Probability Proportional to Size (PPS), with an expected sample size of 16000. Participants will complete the "Lung Cancer Health Questionnaire" to collect individual-level confounding factors. Screening data will be collected through the "Fei'anxin" mini-program, and diagnostic data will be provided by designated hospitals and the First Affiliated Hospital of Guangzhou Medical University. The primary outcome of the study is the proportion of early-stage lung cancer in the screening population, defined as the number of early-stage lung cancer cases divided by the total number of people screened. An economic evaluation of the lung cancer CT screening will also be conducted.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 16,000 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.
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1.Community Health Service Centers (Cluster Level)
Inclusion Criteria The community health service center must be located within one of the 11 districts of Guangzhou.
The center must manage a population of over 10,000 elderly individuals. The center should be equipped with at least one CT machine and have qualified medical personnel, such as radiologists, radiologic technicians, and nursing staff.
Community health service centers where researchers cannot collect data or conduct follow-up.
Inclusion Criteria Aged 40-75 years. Residing in the community participating in the study for a long time. No known history of lung cancer and has not undergone lung cancer screening in the past three months.
Able to understand and willing to sign the informed consent form, and able to participate in long-term follow-up.
Individuals unable to understand the study protocol or who cannot provide informed consent due to cognitive impairments.
Individuals participating in other clinical trials that may affect the results of this study.
Individuals unable to undergo follow-up.
Device: Low-dose CT screening · Device: AI full-lung model interpretation system · Device: Digital Health Platform
Low-dose CT screening is conducted at primary healthcare institutions, and patients with detected lung nodules are referred to hospitals for further examination
Using artificial intelligence technology to assist in the interpretation of CT images
Community health centers and streets in Guangzhou use a program called "Fei Anxin" to manage residents' information in a unified way
The early diagnosis rate of lung cancer
Time frame: Within 1 year after the intervention is implemented
The number of participants in lung cancer screening
Time frame: Within 1 year after the intervention is implemented
Number of individuals with positive screening results
Time frame: Within one year after the intervention is implemented
3-month follow-up rate.
Time frame: Within three months after the intervention is implemented
One-year follow-up rate
Time frame: Within 1 year after the intervention is implemented
Diagnosis rate
Time frame: Within 1 year after the intervention is implemented
False positive rate for nodules
Time frame: Within 1 year after the intervention is implemented
Positive predictive value for nodules
Time frame: Within 1 year after the intervention is implemented
Average time to read CT images
Time frame: Within 1 year after the intervention is implemented
CT screening complications
Time frame: Within 1 year after the intervention is implemented
Complications of diagnostic tests
Time frame: Within 1 year after the intervention is implemented
Plan to share: No
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The First Affiliated Hospital of Guangzhou Medical University