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Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic (PAPESCO-19)

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnostic test for SARS-Cov2 for patients and health staff
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for COVID-19 focused on measuring COVID-19, Cancer patients, Health staff

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Institut de Cancerologie de l'Ouest
  • Centre Jean Perrin
  • Institut de Cancérologie de Lorraine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic test for SARS-Cov2 for patients and health staff

Arm Description

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

Outcomes

Primary Outcome Measures

Establishment of a clinical basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
The clinical basis will done through a Covid 19 clinical signs follow-up questionnaire.
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M0. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M3. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M6. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M9. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M12. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.

Secondary Outcome Measures

Dosage of IgM and IgG anti SARS-CoV2
The evaluation will be done through the dosage of IgM and IgG anti-SARS-CoV2 at different time of measurement M0, M3, M6, M9 and M12 using a qualitive immunochomatographic test and quantitative ELISA test.
Evaluate the diagnostic performance of the minute test for IgM
The result obtained by the qualitative minute test for IgM will be compared to the quantitative ELISA test to know the specificity, sensitivity, positive predictive value, negative predictive value
Evaluate the quantification of IgG in long term (M12) in the Cancer Centres populations
The quantification of IgG level at M12 will be obtained by using the quantitative ELISA test for patients in cancer centres and health staff.
Evaluate the frequency of reinfections among the persons who have developed IgG
The evaluation will be done on subjects who had previously developed IgG and have clinical signs of Covid-19. The signs will be confirmed by RT-PCR which detect the RNA of SARS-CoV2 using a nasal swab test.
Evaluate the threshold of protective IgG among the subjects who have developed IgG
The evaluation is based on whether or not a reinfection occurs during follow-up and it will be done by the concentration of IgG anti-SARS-CoV2 using the quantitative ELISA test.
Evaluate the influence of polymorphisms of receptor of IgG Fc-gamma low-affinity (FcδIIA, FcδIIIa) on the humoral immune response
The evaluation will be done by analysing the anti-SARS-CoV2 antibodies according to the FCGR2A and FCGR3A genotypes using RT-PCR
Evaluate the severity of Covid-19 infection (invisible, visible, prolonged, severe and fatal) by age group
The evaluation will be done by knowing the number of Covid-19-realated death, severe infections (oxygen therapy needed), moderate infections, prolonged symptomatic infections and asymptomatic infections reported to all subjects with a positive serology and/or a positive RT-PCR test.
Evaluate the frequency of reinfection by Covid-19 (recurrence of evocative clinical symptoms and positive viral PCR or positive IgM serology) during follow-up
The evaluation will be done by knowing the number of subjects who have a recurrence of clinical symptoms and/or positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the quantitative ELISA test or the qualitative minute test)
Evaluate the risk factors (clinical and therapeutic) to develop severe forms of Covid-19 infection in patients
The evaluation will be done on subjects who have a seropositivity and/or a positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the ELISA test or the minute test). The factors that are significantly associated to severe forms or mortality are : current or recent cancer treatment (Immunotherapy, chemotherapy based on the frequency of grade 3/4 neutropenia and/or lymphopenia), radiation therapy, surgery), concomitant treatment, comorbidities, type of cancer and stage, cancer-related medical history, biological markers
Evaluate the changes in health care practice
The evaluation will be done by using the PMSI (Program of medicalisation of information systems). This program allows describing the medical activity in health establishment. It is divided in 4 domains: MCO (Medicine, Surgery, Obstetric and Odontology), Follow-up care and rehabilitation, psychiatry, and home care
Evaluate the resources associated with organizational changes
The evaluation will be done by identifying the monetary value of resources mobilized more or less according to the observed changes at the level of modifications in patient treatment scheme (e.g. chemotherapy, radiotherapy and surgery), teleconsultations, and diagnostic of new cancers
Evaluate the allocated resources
The evaluation will be done by knowing the number of health staff sick leave. The information will be obtained with the human resources data and work medicine.
Evaluate the incidence of Covid-19 infections
The incidence will be obtained by counting the number of subjects infected by SARS-CoV2 (patients and health staff) every four months
Evaluate the distribution of risk factors for contamination in patients and in the general population
The evaluation will be done by doing percentages (qualitative factors) / Average or median (quantitative variables) using the Constances cohort for the general population
Evaluate the anxiety state over time
The evaluation will be done before the screening, 3, 6, 9 and 12 months after the screening through the STAI state (State-Trait Anxiety Inventory) questionnaire with 20 items. It evaluates the felling of apprehension, tension, nervousness, anxiety. It is composed of 20 questions. Each answer is noted form 1 to 4. A high score (more than 48 for men and 55 for women) represents a high level of anxiety.
Evaluate the depression over time
The Depression is evaluated before the screening, 3, 6, 9 and 12 months after the screening through the HADS (Hospital Anxiety and Depression Scale) questionnaire with 14 items. Each answer is coded from 0 to 3.The global score variates from 0 to 42. A high score (from 15 to 42) represents the existence of an anxio-depressive syndrome.
Evaluate the post-traumatic developments
The post-traumatic development is evaluated with the PTGI (post-Traumatic Growth Inventory) with 21 items. Each answer is noted from 0 to 5. A high score represents a change to a very great degree. It evaluates the positive changes perceives such as relating to others, news possibilities, personal strength, spiritual change and appreciation life
Evaluate the change in health care change frequency
The evaluation will be done by analysing the number of time the health care of the patient has been changed using the medical file of the patient.
Evaluate the number of patients concerned by health care changes
The evaluation will be done by analysing the medical file of the patient and calculate the number of patients for which the health care has been changed.
Evaluate the rate of morbidity
The rate of morbidity will be obtained by calculating the number of new cases of disease occurring during the study with the help of the medical file of each patient.
Evaluate the rate of mortality
The rate of mortality will be obtained by calculating the ratio of actual deaths to expected deaths.

Full Information

First Posted
May 18, 2020
Last Updated
July 31, 2023
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT04421625
Brief Title
Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic
Acronym
PAPESCO-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Cancer patients, Health staff

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic test for SARS-Cov2 for patients and health staff
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic test for SARS-Cov2 for patients and health staff
Intervention Description
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)
Primary Outcome Measure Information:
Title
Establishment of a clinical basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Description
The clinical basis will done through a Covid 19 clinical signs follow-up questionnaire.
Time Frame
12 months
Title
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Description
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M0. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.
Time Frame
15 days
Title
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Description
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M3. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.
Time Frame
3 months
Title
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Description
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M6. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.
Time Frame
6 months
Title
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Description
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M9. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.
Time Frame
9 months
Title
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Description
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M12. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Dosage of IgM and IgG anti SARS-CoV2
Description
The evaluation will be done through the dosage of IgM and IgG anti-SARS-CoV2 at different time of measurement M0, M3, M6, M9 and M12 using a qualitive immunochomatographic test and quantitative ELISA test.
Time Frame
screening period, 3 months, 6 monthes, 9 months and 12 months
Title
Evaluate the diagnostic performance of the minute test for IgM
Description
The result obtained by the qualitative minute test for IgM will be compared to the quantitative ELISA test to know the specificity, sensitivity, positive predictive value, negative predictive value
Time Frame
12 months
Title
Evaluate the quantification of IgG in long term (M12) in the Cancer Centres populations
Description
The quantification of IgG level at M12 will be obtained by using the quantitative ELISA test for patients in cancer centres and health staff.
Time Frame
12 months
Title
Evaluate the frequency of reinfections among the persons who have developed IgG
Description
The evaluation will be done on subjects who had previously developed IgG and have clinical signs of Covid-19. The signs will be confirmed by RT-PCR which detect the RNA of SARS-CoV2 using a nasal swab test.
Time Frame
12 months
Title
Evaluate the threshold of protective IgG among the subjects who have developed IgG
Description
The evaluation is based on whether or not a reinfection occurs during follow-up and it will be done by the concentration of IgG anti-SARS-CoV2 using the quantitative ELISA test.
Time Frame
12 months
Title
Evaluate the influence of polymorphisms of receptor of IgG Fc-gamma low-affinity (FcδIIA, FcδIIIa) on the humoral immune response
Description
The evaluation will be done by analysing the anti-SARS-CoV2 antibodies according to the FCGR2A and FCGR3A genotypes using RT-PCR
Time Frame
12 months
Title
Evaluate the severity of Covid-19 infection (invisible, visible, prolonged, severe and fatal) by age group
Description
The evaluation will be done by knowing the number of Covid-19-realated death, severe infections (oxygen therapy needed), moderate infections, prolonged symptomatic infections and asymptomatic infections reported to all subjects with a positive serology and/or a positive RT-PCR test.
Time Frame
12 months
Title
Evaluate the frequency of reinfection by Covid-19 (recurrence of evocative clinical symptoms and positive viral PCR or positive IgM serology) during follow-up
Description
The evaluation will be done by knowing the number of subjects who have a recurrence of clinical symptoms and/or positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the quantitative ELISA test or the qualitative minute test)
Time Frame
12 months
Title
Evaluate the risk factors (clinical and therapeutic) to develop severe forms of Covid-19 infection in patients
Description
The evaluation will be done on subjects who have a seropositivity and/or a positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the ELISA test or the minute test). The factors that are significantly associated to severe forms or mortality are : current or recent cancer treatment (Immunotherapy, chemotherapy based on the frequency of grade 3/4 neutropenia and/or lymphopenia), radiation therapy, surgery), concomitant treatment, comorbidities, type of cancer and stage, cancer-related medical history, biological markers
Time Frame
12 months
Title
Evaluate the changes in health care practice
Description
The evaluation will be done by using the PMSI (Program of medicalisation of information systems). This program allows describing the medical activity in health establishment. It is divided in 4 domains: MCO (Medicine, Surgery, Obstetric and Odontology), Follow-up care and rehabilitation, psychiatry, and home care
Time Frame
12 months
Title
Evaluate the resources associated with organizational changes
Description
The evaluation will be done by identifying the monetary value of resources mobilized more or less according to the observed changes at the level of modifications in patient treatment scheme (e.g. chemotherapy, radiotherapy and surgery), teleconsultations, and diagnostic of new cancers
Time Frame
12 months
Title
Evaluate the allocated resources
Description
The evaluation will be done by knowing the number of health staff sick leave. The information will be obtained with the human resources data and work medicine.
Time Frame
12 months
Title
Evaluate the incidence of Covid-19 infections
Description
The incidence will be obtained by counting the number of subjects infected by SARS-CoV2 (patients and health staff) every four months
Time Frame
12 months
Title
Evaluate the distribution of risk factors for contamination in patients and in the general population
Description
The evaluation will be done by doing percentages (qualitative factors) / Average or median (quantitative variables) using the Constances cohort for the general population
Time Frame
12 months
Title
Evaluate the anxiety state over time
Description
The evaluation will be done before the screening, 3, 6, 9 and 12 months after the screening through the STAI state (State-Trait Anxiety Inventory) questionnaire with 20 items. It evaluates the felling of apprehension, tension, nervousness, anxiety. It is composed of 20 questions. Each answer is noted form 1 to 4. A high score (more than 48 for men and 55 for women) represents a high level of anxiety.
Time Frame
screening period, 3 months, 6 monthes, 9 months and 12 months
Title
Evaluate the depression over time
Description
The Depression is evaluated before the screening, 3, 6, 9 and 12 months after the screening through the HADS (Hospital Anxiety and Depression Scale) questionnaire with 14 items. Each answer is coded from 0 to 3.The global score variates from 0 to 42. A high score (from 15 to 42) represents the existence of an anxio-depressive syndrome.
Time Frame
screening period, 3 months, 6 monthes, 9 months and 12 months
Title
Evaluate the post-traumatic developments
Description
The post-traumatic development is evaluated with the PTGI (post-Traumatic Growth Inventory) with 21 items. Each answer is noted from 0 to 5. A high score represents a change to a very great degree. It evaluates the positive changes perceives such as relating to others, news possibilities, personal strength, spiritual change and appreciation life
Time Frame
12 months
Title
Evaluate the change in health care change frequency
Description
The evaluation will be done by analysing the number of time the health care of the patient has been changed using the medical file of the patient.
Time Frame
12 months
Title
Evaluate the number of patients concerned by health care changes
Description
The evaluation will be done by analysing the medical file of the patient and calculate the number of patients for which the health care has been changed.
Time Frame
12 months
Title
Evaluate the rate of morbidity
Description
The rate of morbidity will be obtained by calculating the number of new cases of disease occurring during the study with the help of the medical file of each patient.
Time Frame
12 months
Title
Evaluate the rate of mortality
Description
The rate of mortality will be obtained by calculating the ratio of actual deaths to expected deaths.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Bigot, MD
Organizational Affiliation
Institut de Cancérologie de l'Ouest
Official's Role
Study Director
Facility Information:
Facility Name
Institut de Cancerologie de l'Ouest
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre les nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Learn more about this trial

Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic

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