Evaluation of Pneumoconiosis High Risk Early Warning Models

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04952675
Collaborator
(none)
200
1
88
2.3

Study Details

Study Description

Brief Summary

Precaution of pneumoconiosis is more important than treatment. However, the current process can't early warn the high-risk dust exposed workers until they are diagnosed with pneumoconiosis. With the feature of efficiency, impersonality and quantification, artificial intelligence is just appropriate for solving this problems. Therefore, we are aiming at adapting deep learning to develop models of pneumoconiosis intelligent detection, grade diagnosis and high risk early warning. The annotated images will be used for convolutional neural networks (CNNs) algorithm training, aiming at pneumoconiosis screening and grade diagnosis. Moreover, risk score calculated by density heat map will be used for early warning of dust-exposed workers. Then follow up of cohort will be implied to verify the validity of the risk score. By this way, the high-risk dust-exposed workers will get early intervention and better prognosis, which can obviously reduce medical burden.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Pneumoconiosis, the predominant occupational disease in China and all over the world. Chest radiography is the most accessible and affordable radiological test available for the physical examination of dust-exposed workers and mass screening for pneumoconiosis. But the diagnosis process has some disadvantages, such as strong subjectivity, inefficiency, and disability of judgement of borderline lesion, etc. Besides, precaution of pneumoconiosis is more important than treatment. However, the current process can't early warn the high-risk dust exposed workers until they are diagnosed with pneumoconiosis. With the feature of efficiency, impersonality and quantification, artificial intelligence is just appropriate for solving the aforesaid problems. Up to now, there has been rare research about adapting deep learning for pneumoconiosis grade diagnosis and high risk early warning. In our previous studies, we set up a chest radiograph database, which contains more than 100,000 digital pneumoconiosis radiography images. The result of detection-system evaluation demonstrated that the accuracy in the identification of pneumoconiosis could reach 90%, with an AUC(Area Under The Curve) of 0.965 and a sensitivity of 99%. More works need to be continued. Therefore, we are aiming at adapting deep learning to develop models of pneumoconiosis intelligent detection, grade diagnosis and high risk early warning. The annotated images will be used for convolutional neural networks (CNNs) algorithm training, aiming at pneumoconiosis screening and grade diagnosis. Moreover, risk score calculated by density heat map will be used for early warning of dust-exposed workers. Then follow up of cohort will be implied to verify the validity of the risk score. By this way, the high-risk dust-exposed workers will get early intervention and better prognosis, which can obviously reduce medical burden.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Development and Clinical Application of Pneumoconiosis High Risk Early Warning Models Based on Convolutional Neural Network in Chest Radiography
    Actual Study Start Date :
    Aug 1, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    low-risk group

    Risk Index∈[0,0.5)

    high-risk group

    Risk Index∈[0.5,1)

    Outcome Measures

    Primary Outcome Measures

    1. participants diagnosed as "pneumoconiosis" [before December, 31,2022]

      Number of Participants diagnosed as "pneumoconiosis"

    2. death [before December, 31,2022]

      Number of Participants who dies

    Secondary Outcome Measures

    1. Forced Expiratory Volume In 1s(FEV1) in % [before December, 31,2022]

      Forced Expiratory Volume In 1s

    2. arterial partial pressure of oxygen, PaO2 [before December, 31,2022]

      arterial partial pressure of oxygen

    3. modified Medical Research Council,mMRC [before December, 31,2022]

      a questionnaire used to assess symptom

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. workers exposed to dust;

    2. have digital chest radiography

    Exclusion Criteria:
    1. basal pulmonary disease;

    2. dimission from dust-exposed work

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Third Hospital Beijing Beijing China 100191

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    • Principal Investigator: Xiao Li, M.D., Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT04952675
    Other Study ID Numbers:
    • PekingUTH-002
    First Posted:
    Jul 7, 2021
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking University Third Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2021