ITMO public health
Last update : 12/15/2020 | Version : 1 | ID : 73849
| General | |
| Identification | |
| Detailed name | Evaluation of a ddPCR technology for the SARS-CoV-2 detection based on different types of samples in cancer patients with suspicion of COVID-19 (symptomatic) |
| Sign or acronym | ONCOVID-21 |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP - Ile de France 8 - 20 06 32 |
| General Aspects | |
| Medical area |
Cancer research Infectious diseases |
| Study in connection with Covid-19 |
Yes |
| Pathology (details) | SARS-CoV-2 detection in cancer patients |
| Keywords | SARSCOV2, CANCER, ddPCR, RT-qPCR, SEROLOGICAL ASSAYS |
| Scientific investigator(s) (Contact) | |
| Name of the director | MASTROIANNI |
| Surname | BENEDICTE |
| Address |
CENTRE LEON BERARD 28 RUE LAENNEC 69373 LYON CEDEX 08 |
| Unit | Medical Oncology Department |
| Organization | CENTRE LEON BERARD |
| Collaborations | |
| Funding | |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CENTRE LEON BERARD |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Database objective | |
| Main objective |
To determine the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA IgG) as gold/reference standard (FDA validated commercial serologic test).
The primary endpoint will be the sensibility of the ddPCR assay for SARS-CoV-2 detection based on nasopharyngeal samples. |
| Inclusion criteria |
1. Age ≥ 18 years on the day of signing informed consent.
2. Confirmed diagnosis of any type of solid or hematologic tumor. 3. Ongoing anticancer treatment at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure) 4. Suspicion of COVID-19 infection. Patients must not have underwent diagnostic test and/or chest imaging before inclusion. * At least one of the following clinical symptoms: fever (>38°C), dry cough, fatigue, pulmonary involvement (febrile respiratory infection or respiratory difficulties), pharyngalgia, headaches, myalgia, gastrointestinal symptoms including abdominal pain and diarrhea, anosmia and agueusia, radiological signs of pneumonia as described by Shi et al. 5. Covered by a medical/health insurance. 6. Signed and dated informed consent form. |
| Population type | |
| Population covered |
Sick population |
| Pathology | II - Neoplasms |
| Geography area |
Local |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2020 |
| Date of last collection (YYYY or MM/YYYY) | 2021 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Data | |
| Type of data collected |
Clinical data Biological data |
| Details of collected clinical data | MEDICAL HISTORY, CANCER HISTORY, CLINICAL EXAMINATION, ANTI-CANCER TREATMENTS, SYMPTOMS, RESULTS OF ddPCR, RT-qPCR AND SEROLOGY |
| Biological data (detail) | HEMATOLOGY, BLOOD CHEMISTRY |
| Procedures | |
| Followed pathology | |
| Promotion and access | |
| Promotion | |
| Access |
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