Clinical trial NCT06988943: Early Intervention Strategies for Lung Cancer
Official title: Construction and Evaluation of a Hospital-Community Health Collaboration Model Empowered by Digital Technology for Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Lung Neoplasms
Keywords: Screning test
Lung cancer
LDCT
Low-dose CT
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 16000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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. 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.

Primary outcomes:
measure: The early diagnosis rate of lung cancer
timeFrame: Within 1 year after the intervention is implemented
Secondary outcomes:
measure: The number of participants in lung cancer screening
timeFrame: Within 1 year after the intervention is implemented
measure: Number of individuals with positive screening results
timeFrame: Within one year after the intervention is implemented
measure: 3-month follow-up rate.
timeFrame: Within three months after the intervention is implemented
measure: One-year follow-up rate
timeFrame: Within 1 year after the intervention is implemented
measure: Diagnosis rate
timeFrame: Within 1 year after the intervention is implemented
measure: False positive rate for nodules
timeFrame: Within 1 year after the intervention is implemented
measure: Positive predictive value for nodules
timeFrame: Within 1 year after the intervention is implemented
measure: Average time to read CT images
timeFrame: Within 1 year after the intervention is implemented
measure: CT screening complications
timeFrame: Within 1 year after the intervention is implemented
measure: Complications of diagnostic tests
timeFrame: Within 1 year after the intervention is implemented
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
Study officials:
affiliation: Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
name: Jianxing He, MD
role: PRINCIPAL_INVESTIGATOR
References: