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

NCT04517097 | Completed

• 1 other identifier: 2020-A00877-32
• Study Type: observational
• Target: 1,680
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

SARS-CoV-2; seroprevalence

Outcome Measures

Primary Outcomes (1)

• seroprevalence of SARS-CoV-2

  rate of specific SARC-Cov-2 IgM and IgG

  inclusion

Study Arms (2)

patient group

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

Biological: blood sample

salaried staff group

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

Biological: blood sample

Interventions

blood sample BIOLOGICAL

one blood sample and one questionnaire to each patient and salaried staff included

Also known as: questionnaire

patient group; salaried staff group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges-François LECLERC

Dijon, 21000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: May 12, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

FR (1)