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| Column | Value |
|---|---|
| Trial registration number | NCT04935528 |
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Full text link
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
sladoire@cgfl.fr |
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Registration date
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
2021-06-23 |
|
Recruitment status
Last imported at : June 5, 2023, 8 a.m. Source : ClinicalTrials.gov |
Unknown |
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Study design
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria : group 1 salaried staff of the georges-françois leclerc center over 18 years old subject vaccinated against sars-cov-2 for at least 1 month (last injection), and less than 4 months (last injection). subject who gave his consent to this study subject affiliated to a social security scheme group 2 salaried staff of the georges françois leclerc center over 18 years old subject not vaccinated against sars-cov-2 subject having presented a proven infection by sars-cov-2 (pcr) subject who participated in the canserocov study with a positive serology result subject who gave his consent to this study subject affiliated to a social security scheme group 3 patient over 18 years of age treated in oncology at the gf leclerc center for: metastatic colorectal cancer beyond the first line of treatment metastatic pancreatic cancer as the first line of treatment metastatic breast cancer treated with anti-cdk4 / 6 + hormone therapy, or localized breast cancer treated with (neo) adjuvant chemotherapy patient vaccinated against sars-cov-2 for at least 1 month (last injection), and less than 4 months (last injection) with a vaccination performed when the anti-cancer treatment had been started for at least 1 month (last injection) ) (see diagram below) patient having signed the informed consent for the study patient affiliated to the social security scheme |
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
groups 1, 2 and 3 minor or under legal protection person deprived of liberty or under guardianship (including curatorship) inability to undergo medical monitoring of the trial for geographical, social or psychological reasons (filling in the questionnaire and taking the blood sample) refusal of the patient or employee to participate pregnant or breastfeeding woman |
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Number of arms
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
Centre Georges Francois Leclerc |
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Inclusion age min
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
None |
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Countries
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
France |
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Type of patients
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
430 |
|
primary outcome
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
seroprevalence of SARS-CoV-2 and ELISPOT |
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Notes
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
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Arms
Last imported at : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "vaccined salaried staff (group 1) vs vaccinated patients (group 2)", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "non vaccinated salaried staff (group 3)", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |