Early Intervention Strategies for Lung Cancer

Not Applicable

Recruiting

• Conditions: Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms

• Registration Number: NCT06988943
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Study Start: 2024-06-25
• Status Verified: 2025-05
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-23
• Study First Posted: 2025-05-25
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The early diagnosis rate of lung cancer	Within 1 year after the intervention is implemented

Secondary Outcome Measures

Name	Time	Method
The number of participants in lung cancer screening	Within 1 year after the intervention is implemented
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
False positive rate for nodules	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

Trial Locations

Locations (1)

Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College; 🇨🇳 Guangzhou, Guangdong, China