COVID-19PAPESCO-19NCT04421625
Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic
A study testing Diagnostic test for SARS-Cov2 for patients and health staff in people with COVID-19, run by Institut Cancerologie de l'Ouest at 3 sites in France.
Trial summary
The Covid-19 has, in a few weeks, made the world tremble: the number of deaths (mainly elderly and / or co-morbid) continues to increase, the confinement causes the collapsing of the economy and the decline of relationships inter-human. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Diagnostic test for SARS-Cov2 for patients and health staff
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,102 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Jun 2020to 28 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Population in Cancer centres responding to one of these 3 definitions: patients having a treatment in process, patients under surveillance ( having completed their treatment for more than a year), health staff.
- Subjects who may or may not have had an infection compatible or proven with a Covid-19 infection.
- Information to the participants and signature of the informed consent.
- Subject affiliated with a social insurance
Who cannot join
- Refusal of consent
- Patients who are unable to consent or have a psychiatric history
- Inability to submit to the medical follow-up of the study for geographical, social or psychological reasons
- Person under guardianship or protection of vulnerable adults
- Person deprived of liberty by a judicial or administrative decision
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut de Cancerologie de l'Ouest
Angers, 49055
Centre Jean Perrin
Clermont-Ferrand, 63011
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic: Constitution of a Biological Collection Linked to a Prospective, Multicenter Cohort Study
The Covid-19 has, in a few weeks, made the world tremble: the number of deaths (mainly elderly and / or co-morbid) continues to increase, the confinement causes the collapsing of the economy and the decline of relationships inter-human. The data are too fragmented and the disease too recent to know its repercussions on the 3 million French people who have or have had cancer. The investigators would like, in 3 populations: * patients in treatment, * or in follow-up and * health personnel, to constitute a large prospective and longitudinal database of data: i / serological: humoral response, test performance, monitoring of serum immunoglobulin levels , reinfection threshold,…; ii / clinical: incidence, severity, mortality and their favorable factors impact of cancer treatment on Covid-19 infection and modification of the quality of oncological care in the context. In parallel, on a more limited sample of establishments, it will be : * appreciate the economic and functional repercussions, * will try to find out about the infection modalities in patients and health personnel and * will appreciate the levels of anxiety and depression to which health staff are subject.
Read the detailed description
The participation of the study will be offered to each patient when they will come to the centre (by oncologist, radiotherapist, surgeon, ...). For the health staff, the information can be delivered through different channels (posting, mail, mail, intranet...). This will make the informed consent available to all staff. Participation will be voluntary: staff who have read the information note and wish to participate in the study will have to register on the "PAPESCO-01" screening schedule, during which they will sign their consent with the occupational physician (or anyone delegated by occupational medicine), then have their first sample and complete the various questionnaires.
The screening of the patients and of the health staff will be done by 2 or 3 techniques depending of the results. The first technic is a blood test done at M0 (inclusion), M3, M6, M9 and M12 and on demand in case of Covid-19 symptoms (rapid serology (immediate analysis), ELISA serology (differed analysis on frozen sample), genotyping of FCGR2A and FCGR3A gens (only at M0)). The second technic nasal swab test (RT-PCR) is done only in case of symptoms (whatever the result of the minute test is) for the hospitalized patients. The results of the tests realised in town will be get back through the questionnaires. The third technic is the questionnaires to the patients and the health staff.
- Conditions
- COVID-19
- Being tested
- Diagnostic test for SARS-Cov2 for patients and health staff
- Keywords
- COVID-19, Cancer patients, Health staff
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test for SARS-Cov2 for patients and health staffDiagnostic test
Diagnostic test for SARS-CoV2 :
- Blood test to analyse the IgG and IgM with an immediate qualitative analysis (serological test) and a differed quantitative analysis (ELISA test)
- Results of nasal swab that will allow extracting the RNA and realizing a RT-PCR (only if the participants present symptoms). It will be obtained by standard local laboratories.
- Questionnaires (based on serology, clinic, economy (socio-demographic and lifestyle questionnaire) and epidemiology)
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic test for SARS-Cov2 for patients and health staff | Experimental | * Blood test (rapid serology (immediate analysis), ELISA serology (differed analysis on frozen sample), genotyping of FCGR2A and FCGR3A gens)
* Nasal swab test (only if the patient has symptoms)
* Questionnaires Receives: Diagnostic Test: Diagnostic test for SARS-Cov2 for patients and health staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Severity of Confirmed COVID-19 Infections Among Cancer Centre Staff and Patients at 12 Months
COVID-19 severity will be assessed using the World Health Organization Clinical Progression Scale, which ranges from 0 (uninfected) to 10 (death). Higher scores indicate worse clinical status. COVID-19 infection will be confirmed by PCR or antigen test. Data on symptoms and progression will be collected through a COVID-19 clinical signs follow-up questionnaire and verified by medical records. The outcome will report both the number of participants with confirmed infection and the distribution of severity scores across the scale.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 Jun 2020
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Bigot, MD, Study director, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421625
- Sponsor's protocol ID
- ICO-2020-16
- Acronym
- PAPESCO-19
- Status last verified
- Jul 2023
- First submitted
- 18 May 2020
- Last updated
- 30 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic: Constitution of a Biological Collection Linked to a Prospective, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04421625
- Acronym / sponsor ID
- PAPESCO-19 / ICO-2020-16
- Conditions
- COVID-19
- Keywords
- COVID-19, Cancer patients, Health staff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,102 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 30 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Covid-19 has, in a few weeks, made the world tremble: the number of deaths (mainly elderly and / or co-morbid) continues to increase, the confinement causes the collapsing of the economy and the decline of relationships inter-human. The data are too fragmented and the disease too recent to know its repercussions on the 3 million French people who have or have had cancer. The investigators would like, in 3 populations: * patients in treatment, * or in follow-up and * health personnel, to constitute a large prospective and longitudinal database of data: i / serological: humoral response, test performance, monitoring of serum immunoglobulin levels , reinfection threshold,…; ii / clinical: incidence, severity, mortality and their favorable factors impact of cancer treatment on Covid-19 infection and modification of the quality of oncological care in the context. In parallel, on a more limited sample of establishments, it will be : * appreciate the economic and functional repercussions, * will try to find out about the infection modalities in patients and health personnel and * will appreciate the levels of anxiety and depression to which health staff are subject.
Detailed description
The participation of the study will be offered to each patient when they will come to the centre (by oncologist, radiotherapist, surgeon, ...). For the health staff, the information can be delivered through different channels (posting, mail, mail, intranet...). This will make the informed consent available to all staff. Participation will be voluntary: staff who have read the information note and wish to participate in the study will have to register on the "PAPESCO-01" screening schedule, during which they will sign their consent with the occupational physician (or anyone delegated by occupational medicine), then have their first sample and complete the various questionnaires.
The screening of the patients and of the health staff will be done by 2 or 3 techniques depending of the results. The first technic is a blood test done at M0 (inclusion), M3, M6, M9 and M12 and on demand in case of Covid-19 symptoms (rapid serology (immediate analysis), ELISA serology (differed analysis on frozen sample), genotyping of FCGR2A and FCGR3A gens (only at M0)). The second technic nasal swab test (RT-PCR) is done only in case of symptoms (whatever the result of the minute test is) for the hospitalized patients. The results of the tests realised in town will be get back through the questionnaires. The third technic is the questionnaires to the patients and the health staff.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic test for SARS-Cov2 for patients and health staff | Experimental | Diagnostic Test: Diagnostic test for SARS-Cov2 for patients and health staff* Blood test (rapid serology (immediate analysis), ELISA serology (differed analysis on frozen sample), genotyping of FCGR2A and FCGR3A gens) * Nasal swab test (only if the patient has symptoms) * Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >= 18 years
- Population in Cancer centres responding to one of these 3 definitions: patients having a treatment in process, patients under surveillance ( having completed their treatment for more than a year), health staff.
- Subjects who may or may not have had an infection compatible or proven with a Covid-19 infection.
- Information to the participants and signature of the informed consent.
- Subject affiliated with a social insurance
Key exclusion criteria (5 listed)
- Refusal of consent
- Patients who are unable to consent or have a psychiatric history
- Inability to submit to the medical follow-up of the study for geographical, social or psychological reasons
- Person under guardianship or protection of vulnerable adults
- Person deprived of liberty by a judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic test for SARS-Cov2 for patients and health staffDiagnostic test for SARS-CoV2 : * Blood test to analyse the IgG and IgM with an immediate qualitative analysis (serological test) and a differed quantitative analysis (ELISA test) * Results of nasal swab that will allow extracting the RNA and realizing a RT-PCR (only if the participants present symptoms). It will be obtained by standard local laboratories. * Questionnaires (based on serology, clinic, economy (socio-demographic and lifestyle questionnaire) and epidemiology) | Diagnostic test | Diagnostic test for SARS-Cov2 for patients and health staff |
Primary outcome
Number and Severity of Confirmed COVID-19 Infections Among Cancer Centre Staff and Patients at 12 Months
Time frame: 12 months
COVID-19 severity will be assessed using the World Health Organization Clinical Progression Scale, which ranges from 0 (uninfected) to 10 (death). Higher scores indicate worse clinical status. COVID-19 infection will be confirmed by PCR or antigen test. Data on symptoms and progression will be collected through a COVID-19 clinical signs follow-up questionnaire and verified by medical records. The outcome will report both the number of participants with confirmed infection and the distribution of severity scores across the scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frédéric Bigot, MD study director
Institut de Cancérologie de l'Ouest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic test for SARS-Cov2 for patients and health staff in people with COVID-19, run by Institut Cancerologie de l'Ouest at 3 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 5 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number and Severity of Confirmed COVID-19 Infections Among Cancer Centre Staff and Patients at 12 Months (time frame: 12 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 30 Dec 2025.