Evaluation of Pneumoconiosis High Risk Early Warning Models

July 2, 2021 updated by: Peking University Third Hospital

The Development and Clinical Application of Pneumoconiosis High Risk Early Warning Models Based on Convolutional Neural Network in Chest Radiography

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

dust-exposed workers of 16 provinces of China

Description

Inclusion Criteria:

  1. workers exposed to dust;
  2. have digital chest radiography

Exclusion Criteria:

  1. basal pulmonary disease;
  2. dimission from dust-exposed work

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
low-risk group
Risk Index∈[0,0.5)
high-risk group
Risk Index∈[0.5,1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
participants diagnosed as "pneumoconiosis"
Time Frame: before December, 31,2022
Number of Participants diagnosed as "pneumoconiosis"
before December, 31,2022
death
Time Frame: before December, 31,2022
Number of Participants who dies
before December, 31,2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume In 1s(FEV1) in %
Time Frame: before December, 31,2022
Forced Expiratory Volume In 1s
before December, 31,2022
arterial partial pressure of oxygen, PaO2
Time Frame: before December, 31,2022
arterial partial pressure of oxygen
before December, 31,2022
modified Medical Research Council,mMRC
Time Frame: before December, 31,2022
a questionnaire used to assess symptom
before December, 31,2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

June 23, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (ACTUAL)

July 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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