- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04952675
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
- Name: Xiao Li, M.D.
- Phone Number: +8613051709411
- Email: lixiao.sy@bjmu.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
-
Contact:
- Xiao Li, M.D.
- Phone Number: +8613051709411
- Email: lixiao.sy@bjmu.edu.cn
-
-
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:
- workers exposed to dust;
- have digital chest radiography
Exclusion Criteria:
- basal pulmonary disease;
- 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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PekingUTH-002
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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