NCT04419545

Brief Summary

The possibility to use widespread and simple chest X-ray (CXR) imaging for early screening of COVID-19 patients is attracting much interest from both the clinical and the Artificial intelligence community. In this study we provide insights and also raise warnings on what is reasonable to expect by applying deep learning to COVID classification of CXR images. We provide a methodological guide and critical reading of an extensive set of statistical results that can be obtained using currently available datasets. In particular, we take the challenge posed by current small size COVID data and show how significant can be the bias introduced by transfer-learning using larger public non- COVID CXR datasets. We also contribute by providing results on a medium size COVID CXR dataset, just collected by one of the major emergency hospitals in Northern Italy during the peak of the COVID pandemic. These novel data allow us to contribute to validate the generalization capacity of preliminary results circulating in the scientific community. Our conclusions shed some light into the possibility to effectively discriminate COVID using CXR.

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
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 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

March 24, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

June 4, 2020

Last Update Submit

June 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • sensibility and specificity of neural network diagnosis

    sensibility and specificity of neural network diagnosis compared with human diagnosis

    at day 0

Study Arms (2)

interstitial pneumonia cases

Chest x-ray diagnosis

Diagnostic Test: Neural network diagnosis algorithm

Negative controls

Chest x-ray Negative for pneumonia

Diagnostic Test: Neural network diagnosis algorithm

Interventions

we feed neural network with chest x-ray radiography images for teaching the network for automatic diagnosis of interstitial pneumonia

Negative controlsinterstitial pneumonia cases

Eligibility Criteria

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

All the people treated in radiology dept

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Città della Salute e della Scienza

Torino, Turin, 10126, Italy

RECRUITING

Study Officials

  • Giorgio Limerutti, M.D.

    Radiology Unit A.O.U. Città della Salute e della Scienza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Grosso, M.Sc.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 5, 2020

Study Start

March 24, 2020

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

June 5, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations