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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

NCT ID: NCT06963606

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

22000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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 of residence, lifestyle (smoking, drinking), past medical history, symptom screening, nutritional status, sleep status, mental health status, cognition and acceptance of the application of artificial intelligence in imaging.
2. Pre-test Before the formal cluster randomized controlled trial, a pre-trial involving 100 residents who met the inclusion and exclusion criteria was conducted in two township medical and health institutions to preliminarily verify its effectiveness through the randomized controlled trial and provide suggestions for the performance and potential adjustments of the artificial intelligence-assisted CXR system before the comprehensive trial.
3. Cluster randomized controlled trial 3.1 Intervention Group The subjects who visited the township medical and health institutions in the intervention group, underwent chest DR Examinations, and signed the informed consent form were included in the intervention group, and the visiting time was recorded.

After the completion of the chest DR Examination, the chest X-ray was analyzed by the artificial intelligence-assisted system (JF CXR-1) to identify the potential signs of tuberculosis. Meanwhile, the doctor analyzed the results of the chest X-ray. After the analysis results were confirmed, the initial judgment results of the doctor and the analysis results of the artificial intelligence-assisted system were recorded, and the reading results of the artificial intelligence-assisted system were fed back to the doctor. Review the doctor's comprehensive analysis results of the artificial intelligence-assisted system, make a final judgment on the chest X-ray results, and determine whether further relevant examinations (such as etiological examination, CT examination, etc.) are needed. Record the doctor's judgment results.

Follow up and record the time of diagnosis reported by the tuberculosis specific disease system.

3.2 Control Group The subjects who visited the township medical and health institutions in the control group, underwent chest DR Examinations, and signed the informed consent form were included in the control group, and the visiting time was recorded.

After the chest DR Examination is completed, a regular doctor reviews the films without using an artificial intelligence-assisted system. Once the results of the regular doctor's review are confirmed, a final judgment is made on whether further related examinations (such as etiological tests, CT scans, etc.) are needed, and the doctor's judgment is recorded.

Follow up and record the time of diagnosis reported by the tuberculosis specific disease system.

Conditions

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Tuberculosis (TB)

Keywords

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tuberculosis computer-assisted detection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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computer-assisted detection

Group Type ACTIVE_COMPARATOR

Artificial intelligence-assisted chest X-ray in TB screening

Intervention Type DIAGNOSTIC_TEST

After the completion of the chest DR Examination, the chest X-ray was analyzed by the artificial intelligence-assisted system (JF CXR-1) to identify the potential signs of tuberculosis. Meanwhile, the doctor analyzed the results of the chest X-ray. After the analysis results were confirmed, the initial judgment results of the doctor and the analysis results of the artificial intelligence-assisted system were recorded, and the reading results of the artificial intelligence-assisted system were fed back to the doctor. Review the doctor's comprehensive analysis results of the artificial intelligence-assisted system, make a final judgment on the chest X-ray results, and determine whether further relevant examinations (such as etiological examination, CT examination, etc.) are needed. Record the doctor's judgment results. Follow up and record the time of diagnosis reported by the tuberculosis specific disease system.

Do not use computer-assisted detection

Group Type PLACEBO_COMPARATOR

Routine doctors analyze the process of chest X-rays

Intervention Type OTHER

After the chest DR Examination is completed, a regular doctor reviews the films without using an artificial intelligence-assisted system. Once the results of the regular doctor's review are confirmed, a final judgment is made on whether further related examinations (such as etiological tests, CT scans, etc.) are needed, and the doctor's judgment is recorded. Follow up and record the time of diagnosis reported by the tuberculosis specific disease system

Interventions

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Artificial intelligence-assisted chest X-ray in TB screening

After the completion of the chest DR Examination, the chest X-ray was analyzed by the artificial intelligence-assisted system (JF CXR-1) to identify the potential signs of tuberculosis. Meanwhile, the doctor analyzed the results of the chest X-ray. After the analysis results were confirmed, the initial judgment results of the doctor and the analysis results of the artificial intelligence-assisted system were recorded, and the reading results of the artificial intelligence-assisted system were fed back to the doctor. Review the doctor's comprehensive analysis results of the artificial intelligence-assisted system, make a final judgment on the chest X-ray results, and determine whether further relevant examinations (such as etiological examination, CT examination, etc.) are needed. Record the doctor's judgment results. Follow up and record the time of diagnosis reported by the tuberculosis specific disease system.

Intervention Type DIAGNOSTIC_TEST

Routine doctors analyze the process of chest X-rays

After the chest DR Examination is completed, a regular doctor reviews the films without using an artificial intelligence-assisted system. Once the results of the regular doctor's review are confirmed, a final judgment is made on whether further related examinations (such as etiological tests, CT scans, etc.) are needed, and the doctor's judgment is recorded. Follow up and record the time of diagnosis reported by the tuberculosis specific disease system

Intervention Type OTHER

Eligibility Criteria

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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:

1. \>15 years old.
2. Appearance of tuberculosis-related respiratory symptoms or signs.
3. Individuals not previous diagnosed with active pulmonary tuberculosis.
4. Capable of completing pathogen examinations and subsequent related inspections.

Exclusion Criteria

Those who meet any of the below criteria will be excluded:

1. Diagnosed with extrapulmonary tuberculosis or latent tuberculosis infection during the current visit.
2. The quality of Chest X-ray images did not meet the standard requirements.
3. Unrecognized identity information participants.

Withdrawal Criteria

1. Participants who are lost to follow-up or who do not complete the follow-up period.
2. Participants who experience a sudden and serious illness or choose not to continue participating in the study.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical Board (CMB)

UNKNOWN

Sponsor Role collaborator

Yichang Center for Disease Control and Prevention, China

UNKNOWN

Sponsor Role collaborator

JF Intelligent Healthcare Medical Technology Co

UNKNOWN

Sponsor Role collaborator

Xuelin Yang

OTHER

Sponsor Role lead

Responsible Party

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Xuelin Yang

Project researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wang Ye Prof

Role: STUDY_CHAIR

chool of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing

Locations

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Township Health-care settings in Yichang City

Yichang, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Xuelin

Role: CONTACT

Phone: 0536-13964768397

Email: [email protected]

Su Xiaoyou Prof

Role: CONTACT

Facility Contacts

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Jianhua Liu

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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#24-564

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CAMS&PUMC-IEC-2025-044

Identifier Type: -

Identifier Source: org_study_id