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
Recruiting now · Not applicable
Conditions studied: Tuberculosis (TB)
In brief
The global incidence rate and mortality of tuberculosis (TB) pose a challenge to achieving the goals set out in the tuberculosis eradication strategy and the SDGs by 2030. At present, timely and accessible early detection methods for tuberculosis are still a major obstacle. In this context, the emergence of artificial intelligence (AI), especially the AI-assisted chest X-ray (CXR) in the field of diagnostic imaging, has proved the potential to significantly improve the speed and accuracy of tuberculosis diagnosis. However, the extent to which these technologies can affect the broader tuberculosis care cascade, especially by reducing the diagnostic time in the population level, has not yet been explored. The proposed project plans to use the certified AI-assisted CXR system (JF CXR-1) for tuberculosis screening, which aims not only to integrate AI into the diagnosis process, but also to critically assess its impact on the overall tuberculosis care cascade. The selected location for this project is Yichang City in western Hubei Province, China, which is facing a high TB burden. The city has established a strong city-wide health big data platform ten years ago, providing the basis for this project. The project will first optimize the AI-assisted CXR system through retrospective imaging to validate the accuracy of case screening (Stage Ⅰ). Secondly, the project will shift its focus to the real world, where cluster randomized controlled trials will be conducted in primary-care settings (Stage Ⅱ). In this stage, the effectiveness of the AI-assisted CXR system in reducing the diagnostic time of TB cases will be evaluated by comparing with those settings without using the tool. In stage Ⅲ, the qualitative and quantitative methods will be used to evaluate the generalization, practicality, and feasibility of extending the screening strategy in various community environments. If the AI-assisted screening strategy is proven accurate, effective, and sustainable, it may pave the way for its widespread adoption in primary healthcare institutions and other grassroots areas in China. This can not only improve the timeliness of tuberculosis diagnosis, but also help to allocate medical resources more effectively and significantly reduce tuberculosis-related incidence and mortality, bringing positive changes to global public health. In addition, the results of the project can also provide information for policy decisions and guide the formulation of strategies to prioritize the integration of AI into health care, which can not only fight against tuberculosis but also a series of other diseases.
Key facts
- Study ID
- NCT06963606
- Run by
- Xuelin Yang
- People needed
- 22000
- Starts
- 2025-09-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-12-31
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Those who meet any of the below criteria will be excluded:
- Diagnosed with extrapulmonary tuberculosis or latent tuberculosis infection during the current visit.
- The quality of Chest X-ray images did not meet the standard requirements.
- Unrecognized identity information participants.
- Withdrawal Criteria
- Participants who are lost to follow-up or who do not complete the follow-up period.
- Participants who experience a sudden and serious illness or choose not to continue participating in the study.
Where it is running
- Township Health-care settings in Yichang City — Yichang, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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