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Respiratory Tract NeoplasmsNCT06988943

Early Intervention Strategies for Lung Cancer

A study testing Low-dose CT screening, AI full-lung model interpretation system and Digital Health Platform in people with Respiratory Tract Neoplasms and Thoracic Neoplasms, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 74 yearsHealthy volunteers can take part
What is being tested?
Low-dose CT screening, AI full-lung model interpretation system and Digital Health Platform
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16,000 participants
Where
1 siteChina
Study dates
25 Jun 2024to Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

  1. Screening Subjects (Individual Level)
  2. 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.
  3. 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianxing He, MD contact

86-20-83337792

drjianxing.he@gmail.com

China1 site, 1 recruiting

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

    Guangzhou, Guangdong, 510120

    Jianxing He, MD, +86-20-83337792, drjianxing.he@gmail.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Low-dose CT screening, AI full-lung model interpretation system, Digital Health Platform
Keywords
Screning test, Lung cancer, LDCT, Low-dose CT
Medical subject headings
Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-dose CT screeningDevice

    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 systemDevice

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

  • Digital Health PlatformDevice

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

Study groups in NCT06988943
Study groupRoleWhat they receive
Digitally enabled low-dose CT screening GroupExperimentalNot described
Receives: Device: Low-dose CT screening; Device: AI full-lung model interpretation system; Device: Digital Health Platform

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The early diagnosis rate of lung cancer

    Measured: Within 1 year after the intervention is implemented

Secondary outcomes (10)

  1. The number of participants in lung cancer screening

    Measured: Within 1 year after the intervention is implemented

  2. Number of individuals with positive screening results

    Measured: Within one year after the intervention is implemented

  3. 3-month follow-up rate.

    Measured: Within three months after the intervention is implemented

  4. One-year follow-up rate

    Measured: Within 1 year after the intervention is implemented

  5. Diagnosis rate

    Measured: Within 1 year after the intervention is implemented

  6. False positive rate for nodules

    Measured: Within 1 year after the intervention is implemented

  7. Positive predictive value for nodules

    Measured: Within 1 year after the intervention is implemented

  8. Average time to read CT images

    Measured: Within 1 year after the intervention is implemented

  9. CT screening complications

    Measured: Within 1 year after the intervention is implemented

  10. Complications of diagnostic tests

    Measured: Within 1 year after the intervention is implemented

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2025
  2. Study start25 Jun 2024
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06988943
Sponsor's protocol ID
ES-2024-193-01-001
Status last verified
May 2025
First submitted
16 May 2025
Last updated
30 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Low-dose CT screening, AI full-lung model interpretation system and Digital Health Platform in people with Respiratory Tract Neoplasms and Thoracic Neoplasms, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianxing He, MD (86-20-83337792, drjianxing.he@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The early diagnosis rate of lung cancer (time frame: Within 1 year after the intervention is implemented). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06988943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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