Trial Outcomes & Findings for Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic (NCT NCT04421625)
NCT ID: NCT04421625
Last Updated: 2025-12-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1102 participants
Primary outcome timeframe
12 months
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
Diagnostic Test for SARS-Cov2 for 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
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)
|
Diagnostic Test for SARS-Cov2 for Patients
* 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 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)
|
|---|---|---|
|
Overall Study
STARTED
|
579
|
523
|
|
Overall Study
COMPLETED
|
579
|
523
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Diagnostic Test for SARS-Cov2 for Health Staff
n=579 Participants
* 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 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)
|
Diagnostic Test for SARS-Cov2 for Patients
n=523 Participants
* 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 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)
|
Total
n=1102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 Years
n=579 Participants
|
62 Years
n=523 Participants
|
51 Years
n=1102 Participants
|
|
Sex: Female, Male
Female
|
482 Participants
n=579 Participants
|
377 Participants
n=523 Participants
|
859 Participants
n=1102 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=579 Participants
|
146 Participants
n=523 Participants
|
243 Participants
n=1102 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
579 participants
n=579 Participants
|
523 participants
n=523 Participants
|
1102 participants
n=1102 Participants
|
PRIMARY outcome
Timeframe: 12 monthsCOVID-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.
Outcome measures
| Measure |
Diagnostic test for SARS-Cov2 for health staff
n=579 Participants
* 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 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)
|
Diagnostic test for SARS-Cov2 for patients
n=523 Participants
* 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 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)
|
|---|---|---|
|
Number and Severity of Confirmed COVID-19 Infections Among Cancer Centre Staff and Patients at 12 Months
|
55 Participants
|
36 Participants
|
Adverse Events
Diagnostic Test for SARS-Cov2 for Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diagnostic Test for SARS-Cov2 for Health Staff
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
DR FREDERIC BIGOT
INSTITUT DE CANCEROLOGIE DE L'OUEST
Phone: 02 41 35 27 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place