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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01355-34 | Other Identifier | ANSM ID-RCB number |
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The question of the immune response of the population, particularly of professional populations in contact with vulnerable populations (such as those with chronic conditions such as cancer), is an important issue. Knowing the evolution of this response over time in this population can help answer outstanding questions. The PRO-SERO-COV study is a seroprevalence study of caregivers working in the hospital sector with a follow-up at 3 months and 12 months. The objective is to evaluate and monitor at 3 and 12 months the serological immune status to an infection by the SARS-CoV-2 virus in active volunteer professionals working at the Institut Bergonié with different types of exposure: healthcare professionals and professionals in other services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-SERO-COV | Other | Blood sample and self-administered questionnaire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-SERO-COV | Other | At inclusion, 3 months and 12 months :
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion | Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit. Serum was also tested by ELISA with the SARS-CoV-2 (IgG) ELISA Kit (EuroIm-mun, France). These ELISA and ECLIA tests were carried out in the medical biology laboratory of the Institut Bergonié. Serological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patient and defined as :
| Time 0 (Inclusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months | Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit. Serum was also tested by ELISA with the SARS-CoV-2 (IgG) ELISA Kit (EuroIm-mun, France). These ELISA and ECLIA tests were carried out in the medical biology laboratory of the Institut Bergonié. Serological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patient and defined as :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simone MATHOULIN-PELISSIER, MD, PhD | s.mathoulin@bordeaux.unicancer.fr | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37297553 | Background | Richez B, Cantarel C, Durrieu F, Soubeyran I, Blanchi J, Pernot S, Chakiba Brugere C, Roubaud G, Cousin S, Etienne G, Floquet A, Babre F, Rivalan J, Lalet C, Narbonne M, Belaroussi Y, Bellera C, Mathoulin-Pelissier S. One-Year Follow-Up of Seroprevalence of SARS-CoV-2 Infection and Anxiety among Health Workers of a French Cancer Center: The PRO-SERO-COV Study. Int J Environ Res Public Health. 2023 May 25;20(11):5949. doi: 10.3390/ijerph20115949. |
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Inclusions from June 18th, 2020 to September 28th, 2020 in the Institut Bergonié (Bordeaux, France)
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| ID | Title | Description |
|---|---|---|
| FG000 | PRO-SERO-COV | Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months :
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Inclusion |
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| ||||||||||||||||||||||||
| 3 Months |
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| 12 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO-SERO-COV | Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months :
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion | Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit. Serum was also tested by ELISA with the SARS-CoV-2 (IgG) ELISA Kit (EuroIm-mun, France). These ELISA and ECLIA tests were carried out in the medical biology laboratory of the Institut Bergonié. Serological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patient and defined as :
| Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion | Posted | Count of Participants | Participants | Time 0 (Inclusion) |
|
As this study is an observational study, adverse events and serious adverse events were not collected.
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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 | PRO-SERO-COV | Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months :
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Simone Mathoulin-Pelissier | Institut Bergonié | 0556333333 | S.Mathoulin@bordeaux.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2020 | Jun 23, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D000086382 | COVID-19 |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| 3 months |
| Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months | Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit. ECLIA test was carried out in the medical biology laboratory of the Institut Bergonié. Serological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patients and defined as :
| 12 months |
| Number of Health Care Workers With Active COVID-19 Infection | Defined by a positive result for the molecular test for the detection of the SARS-CoV-2 coronavirus genome by RT-PCR. | Time 0 (inclusion), 3 months, 12 months |
| Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion) | Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points. | Time 0 (inclusion) |
| Number of Health Care Workers With Symptoms of Anxiety at 3 Months | Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points. | 3 months |
| Number of Health Care Workers With Symptoms of Anxiety at 12 Months | Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points. | 12 months |
|
|
| 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 |
|
Blood sample and self-administered questionnaire
PRO-SERO-COV: At inclusion, 3 months and 12 months :
|
|
| Secondary | Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months | Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit. Serum was also tested by ELISA with the SARS-CoV-2 (IgG) ELISA Kit (EuroIm-mun, France). These ELISA and ECLIA tests were carried out in the medical biology laboratory of the Institut Bergonié. Serological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patient and defined as :
| Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and at 3 months | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months | Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit. ECLIA test was carried out in the medical biology laboratory of the Institut Bergonié. Serological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patients and defined as :
| Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion, 3 months and 12 months | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Health Care Workers With Active COVID-19 Infection | Defined by a positive result for the molecular test for the detection of the SARS-CoV-2 coronavirus genome by RT-PCR. | Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion (for 0 month visit) , 3 months (for 3 months visit) and 12 months (for 12 months visit) | Posted | Count of Participants | Participants | Time 0 (inclusion), 3 months, 12 months |
|
|
|
| Secondary | Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion) | Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points. | Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and who signed informed consent form for the optional study and completed the GAD-7 at inclusion | Posted | Count of Participants | Participants | Time 0 (inclusion) |
|
|
|
| Secondary | Number of Health Care Workers With Symptoms of Anxiety at 3 Months | Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points. | Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and who signed informed consent form for the optional study and completed the GAD-7 at 3 months | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Health Care Workers With Symptoms of Anxiety at 12 Months | Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points. | Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and who signed informed consent form for the optional study and completed the GAD-7 at 12 months | Posted | Count of Participants | Participants | 12 months |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001523 | Mental Disorders |
|
| 12 months |
|
|