NCT06988943

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 16, 2025

Last Update Submit

May 26, 2025

Conditions

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLung Neoplasms

Keywords

Screning testLung cancerLDCTLow-dose CT

Outcome Measures

Primary Outcomes (1)

  • The early diagnosis rate of lung cancer

    Within 1 year after the intervention is implemented

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

Digitally enabled low-dose CT screening Group

EXPERIMENTAL
Device: Low-dose CT screeningDevice: AI full-lung model interpretation systemDevice: Digital Health Platform

Interventions

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

Digitally enabled low-dose CT screening Group
AI full-lung model interpretation systemDEVICE

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

Digitally enabled low-dose CT screening Group
Digital Health PlatformDEVICE

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

Digitally enabled low-dose CT screening Group

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Community health service centers where researchers cannot collect data or conduct follow-up.
  • \. Screening Subjects (Individual Level)
  • Able to understand and willing to sign the informed consent form, and able to participate in long-term follow-up.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLung Neoplasms

Study Officials

  • Jianxing He, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianxing He, MD

CONTACT

86-20-83337792drjianxing.he@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 16, 2025

First Posted

May 25, 2025

Study Start

June 25, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)