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NCT06988579Recruiting

The Impact of AI Assistance on Radiologist Performance and Healthcare Costs in LDCT-Based Lung Cancer Screening

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

Source: ClinicalTrials.gov · Last updated 26 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
7294 (estimated)
First submitted
16 May 2025
Start date
1 Jul 2024
Primary completion date
31 Oct 2025
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Diseases
Lung cancer
NCT number
NCT06988579

What you commit to

  • Study type: Interventional
  • Planned participants: 7294
  • From 1 Jul 2024 to the primary completion date, 31 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent participation in other clinical trials that may interfere with study outcomes

Other illness

  • Individuals with a confirmed diagnosis of lung cancer
  • Inability to understand study protocols or provide informed consent due to cognitive impairment

Other

  • Those with severe comorbidities contraindicating CT imaging
  • Unable to comply with follow-up requirements

Who the study is looking for

  • 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

Age in the registry: 40 years to 74 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Guangzhou Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.