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Evaluation of AI-Assisted Versus Conventional Human Reading for Lung Cancer Screening in Community-Based Settings: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

AI diagnostic systems show great promise for improving lung cancer screening in community healthcare settings. While not originally designed for primary care, these tools demonstrate capabilities in nodule detection and workflow optimization. However, their effectiveness in resource-limited community centers requires thorough evaluation. This RCT compares AI-assisted versus manual CT interpretation across community health centers. Expert radiologists will establish reference standards, while an independent committee blindly evaluates cases from both groups. The study assesses diagnostic accuracy, operational efficiency, and cost-effectiveness, with blinded analysts resolving discrepancies through consensus to ensure reliable results.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 74
Healthy Volunteers: t
View:

• Aged 45-74 years

• Permanent resident of participating study communities

• No prior history of lung cancer and no lung cancer screening within the past 3 months

• Able to comprehend and voluntarily sign informed consent, with willingness to participate in long-term follow-up

Locations
Other Locations
China
the First Affiliated Hospital of Guangzhou Medical University,
RECRUITING
Guangzhou
Contact Information
Primary
Jianxing He
drjianxing.he@gmail.com
+8618320729913
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-01-07
Participants
Target number of participants: 7294
Treatments
Experimental: AI-Assisted Group
The AI-assisted group utilized AI-powered diagnostic software for interpreting low-dose computed tomography (LDCT) scans
No_intervention: The manual interpretation group
The manual interpretation group relied on standard radiologist evaluation for analyzing low-dose computed tomography (LDCT) scans.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Guangzhou Medical University

This content was sourced from clinicaltrials.gov