Lung Diseases, Lung Neoplasms, Neoplasms, Neoplasms by Site, Respiratory Tract Diseases, Respiratory Tract Neoplasms, Thoracic Neoplasms
Conditions
Keywords
Screning test, Lung cancer, LDCT, Low-dose CT
Brief summary
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.
Detailed description
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.
Interventions
DEVICELow-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
DEVICEAI full-lung model interpretation system
Using artificial intelligence technology to assist in the interpretation of CT images
DEVICEDigital Health Platform
Community health centers and streets in Guangzhou use a program called Fei Anxin to manage residents' information in a unified way
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
1.Community Health Service Centers (Cluster Level) 1. 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. 2.
Exclusion criteria
Community health centers currently participating in other public health projects or studies that may affect screening results. Community health service centers where researchers cannot collect data or conduct follow-up. 2\. Screening Subjects (Individual Level) 1. 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. 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The early diagnosis rate of lung cancer | Within 1 year after the intervention is implemented |
Secondary
| Measure | Time frame |
|---|---|
| Number of individuals with positive screening results | Within one year after the intervention is implemented |
| 3-month follow-up rate. | Within three months after the intervention is implemented |
| One-year follow-up rate | Within 1 year after the intervention is implemented |
| Diagnosis rate | Within 1 year after the intervention is implemented |
| The number of participants in lung cancer screening | Within 1 year after the intervention is implemented |
| Positive predictive value for nodules | Within 1 year after the intervention is implemented |
| Average time to read CT images | Within 1 year after the intervention is implemented |
| CT screening complications | Within 1 year after the intervention is implemented |
| Complications of diagnostic tests | Within 1 year after the intervention is implemented |
| False positive rate for nodules | Within 1 year after the intervention is implemented |
Countries
China
Contacts
Primary ContactJianxing He, MD
Outcome results
None listed