Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic
- Sponsor
- Institut Cancerologie de l'Ouest
- Study ID
- NCT04421625
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Diagnostic test for SARS-Cov2 for patients and health staff — DIAGNOSTIC_TESTDiagnostic 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)
Study Details
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.
Key Dates
- Start date
- Jun 15, 2020
- Status verified
- Jul 2023
- Primary completion
- Jun 28, 2022
- Completion
- Jun 28, 2022
Study Design
- Enrollment
- 1,102 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SCREENING
Arms
- Experimental: Diagnostic test for SARS-Cov2 for patients and health staff* 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
Primary Outcome Measure
Number and Severity of Confirmed COVID-19 Infections Among Cancer Centre Staff and Patients at 12 Months [ Time Frame: 12 months ]
Related Studies
- Viral Infections in Healthy and Immunocompromised HostsRecruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
- Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT StudyPHASE3 · Recruiting · Ansun Biopharma, Inc. · Duarte, California
- Positron Emission Tomography (PET) Imaging of ThrombosisPHASE1 · Recruiting · Massachusetts General Hospital · Boston, Massachusetts
- Impact of the Coronavirus (COVID-19) on Patients With CancerRecruiting · Stanford University · Stanford, California