Early Intervention Strategies for Lung Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms
• Intervention / Treatment: Device: Low-dose CT screening; Device: AI full-lung model interpretation system; Device: Digital Health Platform

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 Type: Interventional
• Enrollment (Estimated): 16000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianxing He, MD; Phone Number: 86-20-83337792; Email: drjianxing.he@gmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
      • Contact: Jianxing He, MD; Phone Number: +86-20-83337792; Email: drjianxing.he@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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. Exclusion Criteria Individuals diagnosed with lung cancer. Individuals with severe other health issues that make them unsuitable for CT imaging.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Digitally enabled low-dose CT screening Group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The early diagnosis rate of lung cancer	Within 1 year after the intervention is implemented

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Jianxing He, MD, Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 16, 2025
• First Submitted That Met QC Criteria: May 23, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Lung cancer; LDCT; Low-dose CT; Screning test
• Additional Relevant MeSH Terms: Neoplasms; Lung Diseases; Lung Neoplasms; Respiratory Tract Diseases; Thoracic Neoplasms; Respiratory Tract Neoplasms; Neoplasms by Site
• Other Study ID Numbers: ES-2024-193-01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No