Actively Recruiting
Led by Xuelin Yang · Updated on 2025-12-31
22000
Participants Needed
1
Research Sites
N/A
Total Duration
X
Xuelin Yang
Lead Sponsor
C
China Medical Board (CMB)
Collaborating Sponsor
Tuberculosis (TB) remains a major global health challenge with high rates of illness and death, making early and accessible detection critical. This research evaluates the impact of an artificial intelligence (AI)-assisted chest X-ray system (JF CXR-1) in improving TB diagnosis speed and accuracy in primary care settings in Yichang City, China, which faces a high TB burden. The study aims to assess how integrating AI into the diagnosis process can enhance the overall TB care pathway and support public health goals. The study is conducted in three stages: first, retrospective imaging will be used to optimize and validate the AI-assisted system's accuracy. Second, a cluster randomized controlled trial will compare the AI-assisted chest X-ray screening to routine doctor analysis in township medical institutions, measuring diagnostic times and accuracy. Third, qualitative and quantitative methods will evaluate the feasibility and practicality of applying the AI screening approach in various community environments, aiming for wider adoption in primary healthcare. Participants aged over 15 years with TB-related respiratory symptoms who have not been previously diagnosed with active pulmonary TB will undergo chest X-rays. Those in the intervention group will have their X-rays analyzed by the AI-assisted system alongside doctors, while the control group will have standard doctor-only reviews. Researchers will collect baseline data, follow diagnosis timing through the TB disease system, and assess diagnostic yield differences over six and twelve months. The study includes follow-up and monitoring to evaluate the AI system's impact on TB diagnosis and care efficiency.
CONDITIONS
Effectiveness of Computer-Aided Detection Chest X-Ray Screening for Improving Tuberculosis Diagnostic Yield in Chinese Primary Health Care Settings: Study Protocol for a Prospective Cluster Randomized Controlled Trial
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing during study period
Participants undergo chest X-ray examinations analyzed either by an artificial intelligence-assisted system with doctor review or by a regular doctor without AI assistance to identify potential signs of tuberculosis and decide if further tests are needed.
1 visit (in-person)
Duration - Up to 12 months after intervention starts
Participants are followed up to record the time of tuberculosis diagnosis as reported by the tuberculosis specific disease system.
Follow-up visits as needed
Total: 1 location
1
Township Health-care settings in Yichang City
Yichang, Hubei, China, 443000
Actively Recruiting
Y
Yang Xuelin
S
Su Xiaoyou Prof
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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Xuelin Yang, Hao Zhang, Wenjie Jiang...
https://pubmed.ncbi.nlm.nih.gov/41638733