NCT04421625

Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic

Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic: Constitution of a Biological Collection Linked to a Prospective, Multicenter Cohort Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,102 (actual)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic test for SARS-Cov2 for patients and health staff	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)

Timeline

• Start date: 2020-06-15
• Primary completion: 2022-06-28
• Completion: 2022-06-28
• First posted: 2020-06-09
• Last updated: 2025-12-30
• Results posted: 2025-12-30

Locations

3 sites across 1 country: France