Ignite Creation Date:
2024-05-06 @ 2:35 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04367870
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2020-04-28
Brief Title:
COVID-19 Detection Test in Oncology
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
COVID-19 Serodiagnosis in Oncology
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVIDENCE
Brief Summary:
EVIDENCE is a non interventional French multicenter study Patients will be screened by local severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 immunoassay in their oncology department rapid diagnostic test RDT or enzyme-linked immunosorbent assay ELISA In patients with positive local SARS-CoV-2 immunoassay a centralized SARS-CoV-2 ELISA will be performed in order to double check the immune response of all patients considered immune by local immunoassay
Detailed Description:
Patients with cancer are a high-risk group in the COVID-19 pandemic They are already vulnerable to infection because of their underlying illness and often immunosuppressed status and are at increased risk of developing severe complications from the virus including intensive care unit admission or even death In light of this increased risk many guidelines have been issued aiming at minimizing the risk of SARS-CoV-2 infection occurrence andor gravity These changes in cancer care could however translate in less efficient or delayed treatments In this study we want to detect cancer patients that were exposed to the SARS-CoV-2 virus and acquired an immunity These patients immune to the SARS-CoV-2 virus are susceptible to receive the standard of care meaning the most appropriate treatment to manage their cancer Large-scale serodiagnosis are considered as the solution to progressively relax the current lockdown in France RDT and ELISA which were not available until mid-April 2020 will be largely used in the general French population over the coming months millions of tests have already been ordered by French authorities and companies
The aim of this study is to control that oncology patients qualified immune by local immunoassay are indeed safe ie have extremely low risk of SARS-CoV-2 infection following a positive local immunoassay test Of note several immunoassays RDT or ELISA will be used in the participating centers throughout the study A confirmation of positive cases yielded by these different immunoassays will be performed by a centralized ELISA in order to minimize the risk of false positive results
The aim of this study is to control that oncology patients qualified immune by local immunoassay are indeed safe ie have extremely low risk of SARS-CoV-2 infection following a positive local immunoassay test Of note several immunoassays RDT or ELISA will be used in the participating centers throughout the study A confirmation of positive cases yielded by these different immunoassays will be performed by a centralized ELISA in order to minimize the risk of false positive results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A01002-37 | OTHER | ID RCB | None |