Early Intervention Strategies for Lung Cancer

NCT ID: NCT06988943

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2025-06-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Digitally enabled low-dose CT screening Group

Group Type: EXPERIMENTAL

Low-dose CT screening

Intervention Type: DEVICE

Low-dose CT screening is conducted at primary healthcare institutions, and patients with detected lung nodules are referred to hospitals for further examination

AI full-lung model interpretation system

Intervention Type: DEVICE

Using artificial intelligence technology to assist in the interpretation of CT images

Digital Health Platform

Intervention Type: DEVICE

Community health centers and streets in Guangzhou use a program called "Fei Anxin" to manage residents' information in a unified way

Interventions

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

Intervention Type: DEVICE

AI full-lung model interpretation system

Using artificial intelligence technology to assist in the interpretation of CT images

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

Able to understand and willing to sign the informed consent form, and able to participate in long-term follow-up.

Exclusion Criteria

Community health service centers where researchers cannot collect data or conduct follow-up.

2. Screening Subjects (Individual Level)

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jianxing He

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianxing He, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Locations

Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianxing He, MD

Role: CONTACT

drjianxing.he@gmail.com

86-20-83337792

Facility Contacts

Jianxing He, MD

Role: primary

drjianxing.he@gmail.com

+86-20-83337792

Other Identifiers

ES-2024-193-01-001

Identifier Type: -

Identifier Source: org_study_id