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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de l'Ouest, Angers, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic test for SARS-Cov2 for patients and health staff

Diagnostic Test

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)

Primary outcomes

Number and Severity of Confirmed COVID-19 Infections Among Cancer Centre Staff and Patients at 12 Months

Time frame: 12 months

COVID-19 severity will be assessed using the World Health Organization Clinical Progression Scale, which ranges from 0 (uninfected) to 10 (death). Higher scores indicate worse clinical status. COVID-19 infection will be confirmed by PCR or antigen test. Data on symptoms and progression will be collected through a COVID-19 clinical signs follow-up questionnaire and verified by medical records. The outcome will report both the number of participants with confirmed infection and the distribution of severity scores across the scale.

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study 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

Acronym: PAPESCO-19

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jun 9, 2020
Registry last updated: Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed