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

NCT ID: NCT04421625

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2022-06-28

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.

Conditions

COVID-19

Keywords

COVID-19; Cancer patients; Health staff

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Diagnostic test for SARS-Cov2 for patients and health staff

Intervention Type: 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)

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Bigot, MD

Role: STUDY_DIRECTOR

Institut de Cancérologie de l'Ouest

Locations

Institut de Cancerologie de l'Ouest

Angers, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Countries

France

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

ICO-2020-16

Identifier Type: -

Identifier Source: org_study_id