NCT04952675

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 7, 2021

Status Verified

June 1, 2021

Enrollment Period

3.3 years

First QC Date

June 23, 2021

Last Update Submit

July 2, 2021

Conditions

Keywords

artificial intelligencepneumoconiosisDeep Convolutional Neural Networkscomputer-aided diagnosis

Outcome Measures

Primary Outcomes (2)

  • participants diagnosed as "pneumoconiosis"

    Number of Participants diagnosed as "pneumoconiosis"

    before December, 31,2022

  • death

    Number of Participants who dies

    before December, 31,2022

Secondary Outcomes (3)

  • Forced Expiratory Volume In 1s(FEV1) in %

    before December, 31,2022

  • arterial partial pressure of oxygen, PaO2

    before December, 31,2022

  • modified Medical Research Council,mMRC

    before December, 31,2022

Study Arms (2)

low-risk group

Risk Index∈\[0,0.5)

high-risk group

Risk Index∈\[0.5,1)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

dust-exposed workers of 16 provinces of China

You may qualify if:

  • workers exposed to dust;
  • have digital chest radiography

You may not qualify if:

  • basal pulmonary disease;
  • dimission from dust-exposed work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Pneumoconiosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung InjuryOccupational Diseases

Study Officials

  • Xiao Li, M.D.

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 7, 2021

Study Start

August 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2025

Last Updated

July 7, 2021

Record last verified: 2021-06

Locations