Clinical trial NCT04421625: Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic
Official title: Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic: Constitution of a Biological Collection Linked to a Prospective, Multicenter Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Cancer patients
Health staff
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 2307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Population in Cancer centres responding to one of these 3 definitions: patients having a treatment in process, patients under surveillance ( having completed their treatment for more than a year), health staff.
* Subjects who may or may not have had an infection compatible or proven with a Covid-19 infection.
* Information to the participants and signature of the informed consent.
* Subject affiliated with a social insurance

Exclusion Criteria:

* Refusal of consent
* Patients who are unable to consent or have a psychiatric history
* Inability to submit to the medical follow-up of the study for geographical, social or psychological reasons
* Person under guardianship or protection of vulnerable adults
* Person deprived of liberty by a judicial or administrative decision

Primary outcomes:
measure: Establishment of a clinical basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
timeFrame: 12 months
measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
timeFrame: 15 days
measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
timeFrame: 3 months
measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
timeFrame: 6 months
measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
timeFrame: 9 months
measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
timeFrame: 12 months
Secondary outcomes:
measure: Dosage of IgM and IgG anti SARS-CoV2
timeFrame: screening period, 3 months, 6 monthes, 9 months and 12 months
measure: Evaluate the diagnostic performance of the minute test for IgM
timeFrame: 12 months
measure: Evaluate the quantification of IgG in long term (M12) in the Cancer Centres populations
timeFrame: 12 months
measure: Evaluate the frequency of reinfections among the persons who have developed IgG
timeFrame: 12 months
measure: Evaluate the threshold of protective IgG among the subjects who have developed IgG
timeFrame: 12 months
measure: Evaluate the influence of polymorphisms of receptor of IgG Fc-gamma low-affinity (FcδIIA, FcδIIIa) on the humoral immune response
timeFrame: 12 months
measure: Evaluate the severity of Covid-19 infection (invisible, visible, prolonged, severe and fatal) by age group
timeFrame: 12 months
measure: Evaluate the frequency of reinfection by Covid-19 (recurrence of evocative clinical symptoms and positive viral PCR or positive IgM serology) during follow-up
timeFrame: 12 months
measure: Evaluate the risk factors (clinical and therapeutic) to develop severe forms of Covid-19 infection in patients
timeFrame: 12 months
measure: Evaluate the changes in health care practice
timeFrame: 12 months
measure: Evaluate the resources associated with organizational changes
timeFrame: 12 months
measure: Evaluate the allocated resources
timeFrame: 12 months
measure: Evaluate the incidence of Covid-19 infections
timeFrame: 12 months
measure: Evaluate the distribution of risk factors for contamination in patients and in the general population
timeFrame: 12 months
measure: Evaluate the anxiety state over time
timeFrame: screening period, 3 months, 6 monthes, 9 months and 12 months
measure: Evaluate the depression over time
timeFrame: screening period, 3 months, 6 monthes, 9 months and 12 months
measure: Evaluate the post-traumatic developments
timeFrame: 12 months
measure: Evaluate the change in health care change frequency
timeFrame: 12 months
measure: Evaluate the number of patients concerned by health care changes
timeFrame: 12 months
measure: Evaluate the rate of morbidity
timeFrame: 12 months
measure: Evaluate the rate of mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de l'Ouest
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Vandoeuvre les nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Frédéric Bigot, MD
role: STUDY_DIRECTOR
References: