Status:
RECRUITING
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
Lead Sponsor:
Xuelin Yang
Collaborating Sponsors:
China Medical Board (CMB)
Yichang Center for Disease Control and Prevention, China
Conditions:
Tuberculosis (TB)
Eligibility:
All Genders
15+ years
Phase:
NA
Brief Summary
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 acces...
Detailed Description
Research Plan 1. Questionnaire survey - Collect general baseline characteristics The general data characteristics involved in this study include age, gender, marital status, occupation, income, place...
Eligibility Criteria
Inclusion
- Eligibility criteria Inclusion criteria
- Participants must receive medical treatment at the primary healthcare hospitals in Yichang City, Hubei Province, and underwent chest X-ray examinations. The participants have to meet the following criteria:
- \>15 years old.
- Appearance of tuberculosis-related respiratory symptoms or signs.
- Individuals not previous diagnosed with active pulmonary tuberculosis.
- Capable of completing pathogen examinations and subsequent related inspections.
- Exclusion criteria
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
22000 Patients enrolled
Trial Details
Trial ID
NCT06963606
Start Date
September 1 2025
End Date
December 31 2027
Last Update
December 31 2025
Active Locations (1)
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1
Township Health-care settings in Yichang City
Yichang, Hubei, China, 443000