NCT04963348

Brief Summary

Pneumoconiosis is relatively prevalent in low/middle-income countries, and it remains a challenging task to accurately and reliably diagnose pneumoconiosis. The investigators implemented a deep learning solution and clarified the potential of deep learning in pneumoconiosis diagnosis by comparing its performance with two certified radiologists. The deep learning demonstrated a unique potential in classifying pneumoconiosis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,881

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
Last Updated

July 15, 2021

Status Verified

June 1, 2021

Enrollment Period

4 years

First QC Date

June 28, 2021

Last Update Submit

July 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • the diagnosis of pneumoconiosis

    The diagnosis and staging of pneumoconiosis were made by an expert panel consisting of certified radiologists and occupational physicians. The diagnosis of pneumoconiosis was confirmed by medical history and previous medical records(chest X-rays and pulmonary function testing).

    up to 6 months

Study Arms (1)

convolutional neural network (CNN)

a classical deep convolutional neural network (CNN) called Inception-V3 was applied to the image sets and validated the classification performance of the trained models

Other: convolutional neural networks (CNNs)

Interventions

CNN architecture named U-Net architecture

Also known as: deep learning technology
convolutional neural network (CNN)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Of these subjects, 923 were diagnosed with pneumoconiosis, 958 were normal. Among these subjects, 163 were females.

You may qualify if:

  • industrial workers with a history of exposure to dust and underwent DR screening of pneumoconiosis from 2015 to 2018

You may not qualify if:

  • patients with poor image quality
  • patients with incomplete clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumoconiosis

Interventions

Convolutional Neural Networks

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung InjuryOccupational Diseases

Intervention Hierarchy (Ancestors)

Neural Networks, ComputerMathematical Concepts

Study Officials

  • Xiaohua Wang

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 15, 2021

Study Start

January 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

July 15, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share