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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic test for SARS-Cov2 for patients and health staff | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic test for SARS-Cov2 for patients and health staff | Diagnostic Test | Diagnostic test for SARS-CoV2 :
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Bigot, MD | Institut de Cancérologie de l'Ouest | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de l'Ouest | Angers | 49055 | France | |||
| Centre Jean Perrin |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic Test for SARS-Cov2 for Health Staff |
Diagnostic test for SARS-Cov2 for patients and health staff: Diagnostic test for SARS-CoV2 :
|
| FG001 | Diagnostic Test for SARS-Cov2 for Patients |
Diagnostic test for SARS-Cov2 for patients and health staff: Diagnostic test for SARS-CoV2 :
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic Test for SARS-Cov2 for Health Staff |
Diagnostic test for SARS-Cov2 for patients and health staff: Diagnostic test for SARS-CoV2 :
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic Test for SARS-Cov2 for Patients |
Diagnostic test for SARS-Cov2 for patients and health staff: Diagnostic test for SARS-CoV2 :
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR FREDERIC BIGOT | INSTITUT DE CANCEROLOGIE DE L'OUEST | 02 41 35 27 00 | +33 | frederic.bigot@ico.unicancer.fr |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2021 | Dec 8, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003955 | Diagnostic Tests, Routine |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Clermont-Ferrand |
| 63011 |
| France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54511 | France |
| BG001 | Diagnostic Test for SARS-Cov2 for Patients |
Diagnostic test for SARS-Cov2 for patients and health staff: Diagnostic test for SARS-CoV2 :
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Diagnostic test for SARS-Cov2 for patients |
Diagnostic test for SARS-Cov2 for patients and health staff: Diagnostic test for SARS-CoV2 :
|
|
|
| 0 |
| 523 |
| 0 |
| 523 |
| 0 |
| 523 |
| EG001 | Diagnostic Test for SARS-Cov2 for Health Staff |
Diagnostic test for SARS-Cov2 for patients and health staff: Diagnostic test for SARS-CoV2 :
| 0 | 579 | 0 | 579 | 0 | 579 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |