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

NCT04421625 | Completed Results

• 1 other identifier: ICO-2020-16
• Study Type: interventional
• Target: 1,102
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Keywords

COVID-19; Cancer patients; Health staff

Outcome Measures

Primary Outcomes (1)

• Number and Severity of Confirmed COVID-19 Infections Among Cancer Centre Staff and Patients at 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.

  12 months

Study Arms (1)

Diagnostic test for SARS-Cov2 for patients and health staff

EXPERIMENTAL

* 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

Diagnostic Test: Diagnostic test for SARS-Cov2 for patients and health staff

Interventions

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)

Diagnostic test for SARS-Cov2 for patients and health staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (3)

Institut de Cancerologie de l'Ouest

Angers, 49055, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: DR FREDERIC BIGOT
• Organization: INSTITUT DE CANCEROLOGIE DE L'OUEST

frederic.bigot@ico.unicancer.fr

02 41 35 27 00

Study Officials

• Frédéric Bigot, MD

  Institut de Cancérologie de l'Ouest

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 9, 2020
• Study Start: June 15, 2020
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: December 30, 2025
• Results First Posted: December 30, 2025

Record last verified: 2023-07

Locations

FR (3)