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 (canSEROcov)

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Biological: blood sample

• Study Type: Observational
• Enrollment (Actual): 1680

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Centre Georges-Francois Leclerc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated in the anti-cancer hospital of the study and all salaried staff of the anti-cancer hospital of the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seroprevalence of SARS-CoV-2	rate of specific SARC-Cov-2 IgM and IgG	inclusion

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; seroprevalence
• Other Study ID Numbers: 2020-A00877-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No