NCT06988943

Early Intervention Strategies for Lung Cancer

Construction and Evaluation of a Hospital-Community Health Collaboration Model Empowered by Digital Technology for Lung Cancer Screening

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16,000 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Tract Neoplasms
• Thoracic Neoplasms
• Neoplasms by Site
• Neoplasms
• Lung Diseases
• Respiratory Tract Diseases
• Lung Neoplasms

Interventions

Type	Name	Description
DEVICE	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
DEVICE	AI full-lung model interpretation system	Using artificial intelligence technology to assist in the interpretation of CT images
DEVICE	Digital Health Platform	Community health centers and streets in Guangzhou use a program called "Fei Anxin" to manage residents' information in a unified way

Timeline

• Start date: 2024-06-25
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2025-05-25
• Last updated: 2025-05-30

Locations

1 site across 1 country: China