OncologyEVIDENCENCT04367870
COVID-19 Detection Test in Oncology
An observational study of Oncology, run by UNICANCER at 7 sites in France.
Trial 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)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- How many people
- 441 participants
- Where
- 7 sitesFrance
- Study dates
- 23 May 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is composed of individuals aged 18 years or older, in an active phase of treatment for any invasive cancer.
Who may be able to join
- Patients ≥18 years old
- Patient diagnosed with invasive cancer (solid tumor only)
- Patient in active phase of cancer treatment (surgery, chemotherapy, radiotherapy, immunotherapy or targeted therapy ongoing or planned within the next month- excepted patient treated by hormonotherapy and targeted therapy alone in adjuvant setting)
- Patient with a local immunoassay realized before inclusion realized during the standard practice with a positive or negative result (test name and reference should be available)
- Information and non-opposition of the patient to the study procedure
Who cannot join
- Person deprived of their liberty or under protective custody or guardianship
- Patients unwilling or unable to comply with the medical follow-up required by the study because of geographic, familial, social, or psychological reasons
- Patients treated for a hematological malignancy
- Life expectancy <6 months
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Hospitalier de Boulogne sur Mer
Boulogne-sur-Mer
Centre Jean Perrin
Clermont-Ferrand
Hopitaux Civils de Colmar
Colmar
Hôpital Universitaire Pitié Salpêtrière
Paris
Institut Curie
Paris
Centre Eugène Marquis
Rennes
Institut Curie
Saint-Cloud
About this study
Official title: COVID-19 Serodiagnosis in Oncology
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.
Read the 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 and/or 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 (i.e. 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.
- Conditions
- Oncology
- Keywords
- Cancer, SARS-CoV-2, COVID-19, coronavirus, serodiagnosis, immunoassay
- Medical subject headings
- Neoplasms, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non immune patient | Patients with a negative SARS-CoV-2 immunoassay | |
| Immune patient | Patients with a positive SARS-CoV-2 immunoassay |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the ability of SARS-CoV-2 immunoassays, following a positive result, to identify patients with very low risk of recurrence of COVID-19 within 3 months.
The primary endpoint of this study is the recurrence of COVID-19 within 3 months following the immunoassay-positive result obtained before the inclusion in the study. The recurrence is defined by the presence of symptoms confirmed either by a positive reverse transcription-polymerase chain reaction (RT-PCR) result for SARS-CoV-2 or by the adjudication committee. Immunoassay will be said positive as per the predefined reference corresponding to the immunoassay.
Measured: 3 months
Secondary outcomes (3)
To estimate the discordance rate between local immunoassay and a centralized ELISA in patients with a positive immunoassay, whatever the immunoassay.
Agreement between the different immunoassays and the centralized ELISA, using the centralized ELISA as benchmark.
Measured: 6 months
To identify patients with very low risk of recurrence of COVID-19 within 6 months following a positive immunoassay result.
COVID-19 recurrence within 6 months following an immunoassay-positive result.
Measured: 6 months
To characterize the evolution over time of the serologic response against SARS-CoV-2 (in a subgroup of patients).
Quantitative and qualitative detection of SARS-CoV-2-related antibodies and immune serum markers at baseline, 2-3 months and 4-6 months post-inclusion, in a subgroup of 200 patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start23 May 2020
- Primary completion31 May 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François-Clément BIDARD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367870
- Sponsor's protocol ID
- UC-TRA-2002
- Other IDs
- 2020-A01002-37
- Acronym
- EVIDENCE
- Status last verified
- May 2022
- First submitted
- 28 Apr 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Serodiagnosis in Oncology
- ClinicalTrials.gov ID
- NCT04367870
- Acronym / sponsor ID
- EVIDENCE / UC-TRA-2002
- Conditions
- Oncology
- Keywords
- Cancer, SARS-CoV-2, COVID-19, coronavirus, serodiagnosis, immunoassay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 23 May 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and/or 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 (i.e. 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non immune patient | – | –Patients with a negative SARS-CoV-2 immunoassay |
| Immune patient | – | –Patients with a positive SARS-CoV-2 immunoassay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of individuals aged 18 years or older, in an active phase of treatment for any invasive cancer.
Key inclusion criteria (5 listed)
- Patients ≥18 years old
- Patient diagnosed with invasive cancer (solid tumor only)
- Patient in active phase of cancer treatment (surgery, chemotherapy, radiotherapy, immunotherapy or targeted therapy ongoing or planned within the next month- excepted patient treated by hormonotherapy and targeted therapy alone in adjuvant setting)
- Patient with a local immunoassay realized before inclusion realized during the standard practice with a positive or negative result (test name and reference should be available)
- Information and non-opposition of the patient to the study procedure
Key exclusion criteria (4 listed)
- Person deprived of their liberty or under protective custody or guardianship
- Patients unwilling or unable to comply with the medical follow-up required by the study because of geographic, familial, social, or psychological reasons
- Patients treated for a hematological malignancy
- Life expectancy <6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the ability of SARS-CoV-2 immunoassays, following a positive result, to identify patients with very low risk of recurrence of COVID-19 within 3 months.
Time frame: 3 months
The primary endpoint of this study is the recurrence of COVID-19 within 3 months following the immunoassay-positive result obtained before the inclusion in the study. The recurrence is defined by the presence of symptoms confirmed either by a positive reverse transcription-polymerase chain reaction (RT-PCR) result for SARS-CoV-2 or by the adjudication committee. Immunoassay will be said positive as per the predefined reference corresponding to the immunoassay.
3 secondary outcomes
To estimate the discordance rate between local immunoassay and a centralized ELISA in patients with a positive immunoassay, whatever the immunoassay.
Time frame: 6 months
To identify patients with very low risk of recurrence of COVID-19 within 6 months following a positive immunoassay result.
Time frame: 6 months
To characterize the evolution over time of the serologic response against SARS-CoV-2 (in a subgroup of patients).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François-Clément BIDARD principal investigator
Institut Curie
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by UNICANCER at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the ability of SARS-CoV-2 immunoassays, following a positive result, to identify patients with very low risk of recurrence of COVID-19 within 3 months. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.