- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04421625
Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic (PAPESCO-19)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Angers, France, 49055
- Institut de Cancérologie de l'Ouest
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Vandoeuvre les nancy, France, 54511
- Institut de Cancérologie de Lorraine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic test for SARS-Cov2 for patients and health staff
|
Diagnostic test for SARS-CoV2 :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establishment of a clinical basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Time Frame: 12 months
|
The clinical basis will done through a Covid 19 clinical signs follow-up questionnaire.
|
12 months
|
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Time Frame: 15 days
|
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M0. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. |
15 days
|
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Time Frame: 3 months
|
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M3. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. |
3 months
|
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Time Frame: 6 months
|
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M6. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. |
6 months
|
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Time Frame: 9 months
|
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M9. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. |
9 months
|
Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.
Time Frame: 12 months
|
The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M12. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dosage of IgM and IgG anti SARS-CoV2
Time Frame: screening period, 3 months, 6 monthes, 9 months and 12 months
|
The evaluation will be done through the dosage of IgM and IgG anti-SARS-CoV2 at different time of measurement M0, M3, M6, M9 and M12 using a qualitive immunochomatographic test and quantitative ELISA test.
|
screening period, 3 months, 6 monthes, 9 months and 12 months
|
Evaluate the diagnostic performance of the minute test for IgM
Time Frame: 12 months
|
The result obtained by the qualitative minute test for IgM will be compared to the quantitative ELISA test to know the specificity, sensitivity, positive predictive value, negative predictive value
|
12 months
|
Evaluate the quantification of IgG in long term (M12) in the Cancer Centres populations
Time Frame: 12 months
|
The quantification of IgG level at M12 will be obtained by using the quantitative ELISA test for patients in cancer centres and health staff.
|
12 months
|
Evaluate the frequency of reinfections among the persons who have developed IgG
Time Frame: 12 months
|
The evaluation will be done on subjects who had previously developed IgG and have clinical signs of Covid-19.
The signs will be confirmed by RT-PCR which detect the RNA of SARS-CoV2 using a nasal swab test.
|
12 months
|
Evaluate the threshold of protective IgG among the subjects who have developed IgG
Time Frame: 12 months
|
The evaluation is based on whether or not a reinfection occurs during follow-up and it will be done by the concentration of IgG anti-SARS-CoV2 using the quantitative ELISA test.
|
12 months
|
Evaluate the influence of polymorphisms of receptor of IgG Fc-gamma low-affinity (FcδIIA, FcδIIIa) on the humoral immune response
Time Frame: 12 months
|
The evaluation will be done by analysing the anti-SARS-CoV2 antibodies according to the FCGR2A and FCGR3A genotypes using RT-PCR
|
12 months
|
Evaluate the severity of Covid-19 infection (invisible, visible, prolonged, severe and fatal) by age group
Time Frame: 12 months
|
The evaluation will be done by knowing the number of Covid-19-realated death, severe infections (oxygen therapy needed), moderate infections, prolonged symptomatic infections and asymptomatic infections reported to all subjects with a positive serology and/or a positive RT-PCR test.
|
12 months
|
Evaluate the frequency of reinfection by Covid-19 (recurrence of evocative clinical symptoms and positive viral PCR or positive IgM serology) during follow-up
Time Frame: 12 months
|
The evaluation will be done by knowing the number of subjects who have a recurrence of clinical symptoms and/or positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the quantitative ELISA test or the qualitative minute test)
|
12 months
|
Evaluate the risk factors (clinical and therapeutic) to develop severe forms of Covid-19 infection in patients
Time Frame: 12 months
|
The evaluation will be done on subjects who have a seropositivity and/or a positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the ELISA test or the minute test).
The factors that are significantly associated to severe forms or mortality are : current or recent cancer treatment (Immunotherapy, chemotherapy based on the frequency of grade 3/4 neutropenia and/or lymphopenia), radiation therapy, surgery), concomitant treatment, comorbidities, type of cancer and stage, cancer-related medical history, biological markers
|
12 months
|
Evaluate the changes in health care practice
Time Frame: 12 months
|
The evaluation will be done by using the PMSI (Program of medicalisation of information systems).
This program allows describing the medical activity in health establishment.
It is divided in 4 domains: MCO (Medicine, Surgery, Obstetric and Odontology), Follow-up care and rehabilitation, psychiatry, and home care
|
12 months
|
Evaluate the resources associated with organizational changes
Time Frame: 12 months
|
The evaluation will be done by identifying the monetary value of resources mobilized more or less according to the observed changes at the level of modifications in patient treatment scheme (e.g.
chemotherapy, radiotherapy and surgery), teleconsultations, and diagnostic of new cancers
|
12 months
|
Evaluate the allocated resources
Time Frame: 12 months
|
The evaluation will be done by knowing the number of health staff sick leave.
The information will be obtained with the human resources data and work medicine.
|
12 months
|
Evaluate the incidence of Covid-19 infections
Time Frame: 12 months
|
The incidence will be obtained by counting the number of subjects infected by SARS-CoV2 (patients and health staff) every four months
|
12 months
|
Evaluate the distribution of risk factors for contamination in patients and in the general population
Time Frame: 12 months
|
The evaluation will be done by doing percentages (qualitative factors) / Average or median (quantitative variables) using the Constances cohort for the general population
|
12 months
|
Evaluate the anxiety state over time
Time Frame: screening period, 3 months, 6 monthes, 9 months and 12 months
|
The evaluation will be done before the screening, 3, 6, 9 and 12 months after the screening through the STAI state (State-Trait Anxiety Inventory) questionnaire with 20 items.
It evaluates the felling of apprehension, tension, nervousness, anxiety.
It is composed of 20 questions.
Each answer is noted form 1 to 4. A high score (more than 48 for men and 55 for women) represents a high level of anxiety.
|
screening period, 3 months, 6 monthes, 9 months and 12 months
|
Evaluate the depression over time
Time Frame: screening period, 3 months, 6 monthes, 9 months and 12 months
|
The Depression is evaluated before the screening, 3, 6, 9 and 12 months after the screening through the HADS (Hospital Anxiety and Depression Scale) questionnaire with 14 items.
Each answer is coded from 0 to 3.The global score variates from 0 to 42.
A high score (from 15 to 42) represents the existence of an anxio-depressive syndrome.
|
screening period, 3 months, 6 monthes, 9 months and 12 months
|
Evaluate the post-traumatic developments
Time Frame: 12 months
|
The post-traumatic development is evaluated with the PTGI (post-Traumatic Growth Inventory) with 21 items.
Each answer is noted from 0 to 5. A high score represents a change to a very great degree.
It evaluates the positive changes perceives such as relating to others, news possibilities, personal strength, spiritual change and appreciation life
|
12 months
|
Evaluate the change in health care change frequency
Time Frame: 12 months
|
The evaluation will be done by analysing the number of time the health care of the patient has been changed using the medical file of the patient.
|
12 months
|
Evaluate the number of patients concerned by health care changes
Time Frame: 12 months
|
The evaluation will be done by analysing the medical file of the patient and calculate the number of patients for which the health care has been changed.
|
12 months
|
Evaluate the rate of morbidity
Time Frame: 12 months
|
The rate of morbidity will be obtained by calculating the number of new cases of disease occurring during the study with the help of the medical file of each patient.
|
12 months
|
Evaluate the rate of mortality
Time Frame: 12 months
|
The rate of mortality will be obtained by calculating the ratio of actual deaths to expected deaths.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Frédéric Bigot, MD, Institut de Cancérologie de l'Ouest
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICO-2020-16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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