<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421625</url>
  </required_header>
  <id_info>
    <org_study_id>ICO-2020-16</org_study_id>
    <nct_id>NCT04421625</nct_id>
  </id_info>
  <brief_title>Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic</brief_title>
  <acronym>PAPESCO-19</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Cancerologie de l'Ouest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Cancerologie de l'Ouest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Covid-19 has, in a few weeks, made the world tremble: the number of deaths (mainly&#xD;
      elderly and / or co-morbid) continues to increase, the confinement causes the collapsing of&#xD;
      the economy and the decline of relationships inter-human. The data are too fragmented and the&#xD;
      disease too recent to know its repercussions on the 3 million French people who have or have&#xD;
      had cancer. The investigators would like, in 3 populations: * patients in treatment, * or in&#xD;
      follow-up and * health personnel, to constitute a large prospective and longitudinal database&#xD;
      of data: i / serological: humoral response, test performance, monitoring of serum&#xD;
      immunoglobulin levels , reinfection threshold,…; ii / clinical: incidence, severity,&#xD;
      mortality and their favorable factors impact of cancer treatment on Covid-19 infection and&#xD;
      modification of the quality of oncological care in the context. In parallel, on a more&#xD;
      limited sample of establishments, it will be : * appreciate the economic and functional&#xD;
      repercussions, * will try to find out about the infection modalities in patients and health&#xD;
      personnel and * will appreciate the levels of anxiety and depression to which health staff&#xD;
      are subject.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participation of the study will be offered to each patient when they will come to the&#xD;
      centre (by oncologist, radiotherapist, surgeon, ...). For the health staff, the information&#xD;
      can be delivered through different channels (posting, mail, mail, intranet...). This will&#xD;
      make the informed consent available to all staff. Participation will be voluntary: staff who&#xD;
      have read the information note and wish to participate in the study will have to register on&#xD;
      the &quot;PAPESCO-01&quot; screening schedule, during which they will sign their consent with the&#xD;
      occupational physician (or anyone delegated by occupational medicine), then have their first&#xD;
      sample and complete the various questionnaires.&#xD;
&#xD;
      The screening of the patients and of the health staff will be done by 2 or 3 techniques&#xD;
      depending of the results. The first technic is a blood test done at M0 (inclusion), M3, M6,&#xD;
      M9 and M12 and on demand in case of Covid-19 symptoms (rapid serology (immediate analysis),&#xD;
      ELISA serology (differed analysis on frozen sample), genotyping of FCGR2A and FCGR3A gens&#xD;
      (only at M0)). The second technic nasal swab test (RT-PCR) is done only in case of symptoms&#xD;
      (whatever the result of the minute test is) for the hospitalized patients. The results of the&#xD;
      tests realised in town will be get back through the questionnaires. The third technic is the&#xD;
      questionnaires to the patients and the health staff.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">June 28, 2022</completion_date>
  <primary_completion_date type="Actual">June 28, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Establishment of a clinical basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.</measure>
    <time_frame>12 months</time_frame>
    <description>The clinical basis will done through a Covid 19 clinical signs follow-up questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.</measure>
    <time_frame>15 days</time_frame>
    <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.&#xD;
The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.</measure>
    <time_frame>3 months</time_frame>
    <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.&#xD;
The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.</measure>
    <time_frame>6 months</time_frame>
    <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.&#xD;
The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.</measure>
    <time_frame>9 months</time_frame>
    <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.&#xD;
The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.</measure>
    <time_frame>12 months</time_frame>
    <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.&#xD;
The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dosage of IgM and IgG anti SARS-CoV2</measure>
    <time_frame>screening period, 3 months, 6 monthes, 9 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the diagnostic performance of the minute test for IgM</measure>
    <time_frame>12 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the quantification of IgG in long term (M12) in the Cancer Centres populations</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the frequency of reinfections among the persons who have developed IgG</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the threshold of protective IgG among the subjects who have developed IgG</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the influence of polymorphisms of receptor of IgG Fc-gamma low-affinity (FcδIIA, FcδIIIa) on the humoral immune response</measure>
    <time_frame>12 months</time_frame>
    <description>The evaluation will be done by analysing the anti-SARS-CoV2 antibodies according to the FCGR2A and FCGR3A genotypes using RT-PCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the severity of Covid-19 infection (invisible, visible, prolonged, severe and fatal) by age group</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the frequency of reinfection by Covid-19 (recurrence of evocative clinical symptoms and positive viral PCR or positive IgM serology) during follow-up</measure>
    <time_frame>12 months</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the risk factors (clinical and therapeutic) to develop severe forms of Covid-19 infection in patients</measure>
    <time_frame>12 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the changes in health care practice</measure>
    <time_frame>12 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the resources associated with organizational changes</measure>
    <time_frame>12 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the allocated resources</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the incidence of Covid-19 infections</measure>
    <time_frame>12 months</time_frame>
    <description>The incidence will be obtained by counting the number of subjects infected by SARS-CoV2 (patients and health staff) every four months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the distribution of risk factors for contamination in patients and in the general population</measure>
    <time_frame>12 months</time_frame>
    <description>The evaluation will be done by doing percentages (qualitative factors) / Average or median (quantitative variables) using the Constances cohort for the general population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the anxiety state over time</measure>
    <time_frame>screening period, 3 months, 6 monthes, 9 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the depression over time</measure>
    <time_frame>screening period, 3 months, 6 monthes, 9 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the post-traumatic developments</measure>
    <time_frame>12 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the change in health care change frequency</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the number of patients concerned by health care changes</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the rate of morbidity</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the rate of mortality</measure>
    <time_frame>12 months</time_frame>
    <description>The rate of mortality will be obtained by calculating the ratio of actual deaths to expected deaths.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2307</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Diagnostic test for SARS-Cov2 for patients and health staff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood test (rapid serology (immediate analysis), ELISA serology (differed analysis on frozen sample), genotyping of FCGR2A and FCGR3A gens)&#xD;
Nasal swab test (only if the patient has symptoms)&#xD;
Questionnaires</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Diagnostic test for SARS-Cov2 for patients and health staff</intervention_name>
    <description>Diagnostic test for SARS-CoV2 :&#xD;
Blood test to analyse the IgG and IgM with an immediate qualitative analysis (serological test) and a differed quantitative analysis (ELISA test)&#xD;
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.&#xD;
Questionnaires (based on serology, clinic, economy (socio-demographic and lifestyle questionnaire) and epidemiology)</description>
    <arm_group_label>Diagnostic test for SARS-Cov2 for patients and health staff</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
          -  Population in Cancer centres responding to one of these 3 definitions: patients having&#xD;
             a treatment in process, patients under surveillance ( having completed their treatment&#xD;
             for more than a year), health staff.&#xD;
&#xD;
          -  Subjects who may or may not have had an infection compatible or proven with a Covid-19&#xD;
             infection.&#xD;
&#xD;
          -  Information to the participants and signature of the informed consent.&#xD;
&#xD;
          -  Subject affiliated with a social insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of consent&#xD;
&#xD;
          -  Patients who are unable to consent or have a psychiatric history&#xD;
&#xD;
          -  Inability to submit to the medical follow-up of the study for geographical, social or&#xD;
             psychological reasons&#xD;
&#xD;
          -  Person under guardianship or protection of vulnerable adults&#xD;
&#xD;
          -  Person deprived of liberty by a judicial or administrative decision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frédéric Bigot, MD</last_name>
    <role>Study Director</role>
    <affiliation>Institut de Cancérologie de l'Ouest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de Cancerologie de l'Ouest</name>
      <address>
        <city>Angers</city>
        <zip>49055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de Lorraine</name>
      <address>
        <city>Vandoeuvre les nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Cancer patients</keyword>
  <keyword>Health staff</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421625
org study id: ICO-2020-16
nct id: NCT04421625
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Establishment of a clinical basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
time frame: 12 months
description: The clinical basis will done through a Covid 19 clinical signs follow-up questionnaire.
measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
time frame: 15 days
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.
measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
time frame: 3 months
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.
measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
time frame: 6 months
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.
measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
time frame: 9 months
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.
measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
time frame: 12 months
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.
measure: Dosage of IgM and IgG anti SARS-CoV2
time frame: screening period, 3 months, 6 monthes, 9 months and 12 months
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.
measure: Evaluate the diagnostic performance of the minute test for IgM
time frame: 12 months
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
measure: Evaluate the quantification of IgG in long term (M12) in the Cancer Centres populations
time frame: 12 months
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.
measure: Evaluate the frequency of reinfections among the persons who have developed IgG
time frame: 12 months
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.
measure: Evaluate the threshold of protective IgG among the subjects who have developed IgG
time frame: 12 months
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.
measure: Evaluate the influence of polymorphisms of receptor of IgG Fc-gamma low-affinity (FcδIIA, FcδIIIa) on the humoral immune response
time frame: 12 months
description: The evaluation will be done by analysing the anti-SARS-CoV2 antibodies according to the FCGR2A and FCGR3A genotypes using RT-PCR
measure: Evaluate the severity of Covid-19 infection (invisible, visible, prolonged, severe and fatal) by age group
time frame: 12 months
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.
measure: Evaluate the frequency of reinfection by Covid-19 (recurrence of evocative clinical symptoms and positive viral PCR or positive IgM serology) during follow-up
time frame: 12 months
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)
measure: Evaluate the risk factors (clinical and therapeutic) to develop severe forms of Covid-19 infection in patients
time frame: 12 months
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
measure: Evaluate the changes in health care practice
time frame: 12 months
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
measure: Evaluate the resources associated with organizational changes
time frame: 12 months
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
measure: Evaluate the allocated resources
time frame: 12 months
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.
measure: Evaluate the incidence of Covid-19 infections
time frame: 12 months
description: The incidence will be obtained by counting the number of subjects infected by SARS-CoV2 (patients and health staff) every four months
measure: Evaluate the distribution of risk factors for contamination in patients and in the general population
time frame: 12 months
description: The evaluation will be done by doing percentages (qualitative factors) / Average or median (quantitative variables) using the Constances cohort for the general population
measure: Evaluate the anxiety state over time
time frame: screening period, 3 months, 6 monthes, 9 months and 12 months
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.
measure: Evaluate the depression over time
time frame: screening period, 3 months, 6 monthes, 9 months and 12 months
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.
measure: Evaluate the post-traumatic developments
time frame: 12 months
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
measure: Evaluate the change in health care change frequency
time frame: 12 months
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.
measure: Evaluate the number of patients concerned by health care changes
time frame: 12 months
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.
measure: Evaluate the rate of morbidity
time frame: 12 months
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.
measure: Evaluate the rate of mortality
time frame: 12 months
description: The rate of mortality will be obtained by calculating the ratio of actual deaths to expected deaths.
arm group label: Diagnostic test for SARS-Cov2 for patients and health staff
arm group type: Experimental
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: Diagnostic test for SARS-Cov2 for patients and health staff
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)
arm group label: Diagnostic test for SARS-Cov2 for patients and health staff
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frédéric Bigot, MD
role: Study Director
affiliation: Institut de Cancérologie de l'Ouest
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19