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canSEROcov: Study of the Specific Seroprevalence of SARS-CoV-2 in a Sample of Patients and Salaried Staff From a French Anti-cancer Center at the End of the Containment Period of the SARS-CoV-2 Pandemic

Sponsor
Centre Georges Francois Leclerc (Other)
Overall Status
Completed
CT.gov ID
NCT04517097
Collaborator
(none)
1,680
Enrollment
1
Location
1.6
Actual Duration (Months)
1043.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Since March 2020, France has been confronted with the SARS-COV-2 pandemic. Analysis of the data of its spread would indicate that close contact between individuals is necessary and containment would be the best way to contain this virus. France has therefore been contained since March 17, 2020 until 11 May 2020.

In order to assess the impact of the measures taken (containment) to protect patients and salaried staff of a french anti-cancer center on the spread of the virus, this observational study assesses the specific seroprevalence of SARS-COV-2 in all caregivers and non-carers of this hospital and in patients treated in consultation, day hospitalization, full hospitalization at the end of the containment period.

The objective for the staff cohort is to describe the seroprevalence and the link between the seroprevalence and sociological / demographic factors relating to the category of profession, to the contacts with the patients, to the presence in the hospital during the period of containment, to the conditions of home containment.

The objective for the patient cohort is to describe the seroprevalence and the link between the seroprevalence and factors relating to the type of cancer treated, the type of treatment and their possible modification during the period of containment, to the conditions of home containment.

Condition or Disease Intervention/Treatment Phase
  • Biological: blood sample

Study Design

Study Type:
Observational
Actual Enrollment :
1680 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of the Specific Seroprevalence of SARS-CoV-2 in a Sample of Patients and Salaried Staff From a French Anti-cancer Center at the End of the Containment Period of the SARS-CoV-2 Pandemic
Actual Study Start Date :
May 12, 2020
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
patient group

patients treated in the french anti-cancer center of the study

Biological: blood sample
one blood sample and one questionnaire to each patient and salaried staff included
Other Names:
  • questionnaire

    		•
    salaried staff group

    all salaried staff of the french anti-cancer center of the study

    Biological: blood sample
    one blood sample and one questionnaire to each patient and salaried staff included
    Other Names:
  • questionnaire

    		•

    Outcome Measures

    Primary Outcome Measures

    1. seroprevalence of SARS-CoV-2 [inclusion]

      rate of specific SARC-Cov-2 IgM and IgG

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patient group:

    Patient over 18 years old. Patient who gave his non-opposition to carrying out the study. Patient affiliated to the social security scheme.

    • Salaried staff group:

    Salaried staff over 18 years old. Salaried staff not opposing the carrying out of the study. Salaried staff affiliated to the social security scheme.

    Exclusion Criteria:
    • Patient group:

    Minor patient, under legal protection or subject to a legal protection measure Patient deprived of liberty or under guardianship Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons Patient refusal to participate Pregnant or nursing mothers

    • Salaried staff group:

    Underage salaried staff or under legal protection Salaried staff deprived of liberty or under guardianship Inability of the salaried staff to submit to the monitoring of the test: filling out the questionnaire and taking a blood sample Salaried staff refusal to participate in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Georges-François LECLERC Dijon France 21000

    Sponsors and Collaborators

    • Centre Georges Francois Leclerc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Georges Francois Leclerc
    ClinicalTrials.gov Identifier:
    NCT04517097
    Other Study ID Numbers:
    • 2020-A00877-32
    First Posted:
    Aug 18, 2020
    Last Update Posted:
    Aug 18, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Georges Francois Leclerc
    SARS-CoV-2
    seroprevalence

    Study Results

    No Results Posted as of Aug 18, 2020