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Multicentric Retrospective Observational Study of Thoracic Scanner Performance in COVID Screening.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04339686
Recruitment Status : Unknown
Verified April 2020 by Poitiers University Hospital.
Recruitment status was:  Recruiting
First Posted : April 9, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:

All patients included in this search will be on anonymized file: Symptomatic patients consulting for suspicion of COVID 19 with indication to a screening (RT-PCR, Scanner) according to the criteria of the Ministry of Health.

To evaluate the diagnostic performance of chest CT in screening for COVID-related lung injury in patients with a clinical suspicion of COVID.

CT scan results for COVID according to French thoracic imaging society will be dichotomized into evocative or compatible (considered positive) non-evocative (considered negative) The results will be compared to the gold standard corresponding to a multiparametric element: the discharge summary.

Ct Scan performance will be recorded and analyzed.


Condition or disease Intervention/treatment
The Gold Standard for Current SARS CoV2 Detection is RT-PCR Diagnostic Test: Thoracic CT Scan

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Study Type : Observational
Estimated Enrollment : 56000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicentric Retrospective Observational Study of Thoracic Scanner Performance in COVID Screening. Comparison to Virological Testing and Multiparametric Gold Standard
Actual Study Start Date : April 20, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Group/Cohort Intervention/treatment
Suspicion of COVID 19 Diagnostic Test: Thoracic CT Scan
Retrospective analysis of the thoracic CT scan results compared to final discharge summary




Primary Outcome Measures :
  1. Diagnostic performance of chest CT in screening for pulmonary lesions in clinical suspicions of COVID. [ Time Frame: 1 month ]
    CT Report will dichotomized into evocative or non-evocative for COVID-related lung injury.


Secondary Outcome Measures :
  1. Compare the diagnostic performance of chest CT and RT-PCR in COVID 19 at the initial consultation (screening). [ Time Frame: 1 month ]

    Initial virological RT-PCR results: positive or negative depending on the laboratories of the institutions.

    Scanner results according to French Thoracic Imaging Society.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients suspected of COVID 19 consulting for diagnostic
Criteria

Inclusion Criteria:

  • All patients suspected of COVID 19 consulting for diagnostic

Exclusion Criteria:

  • Delay between RT-PCR and Thoracic Scan greater than 6 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339686


Contacts
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Contact: Guillaume HERPE 681196778 ext +33 guillaume.herpe@chu-poitiers.fr

Locations
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France
Chu de Poitiers Recruiting
Poitiers, France
Contact: Guillaume HERPE         
Sponsors and Collaborators
Poitiers University Hospital
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT04339686    
Other Study ID Numbers: POWER-COVID_CT
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No