ITMO public health
Last update : 12/09/2020 | Version : 1 | ID : 73838
| General | |
| Identification | |
| Detailed name | Prospective analysis of morbi-mortality of patients with cancers in active phase of treatment suspected or diagnosed of a SARS-CoV-2 infection |
| Sign or acronym | ONCOVID-19 |
| General Aspects | |
| Medical area |
Cancer research |
| Study in connection with Covid-19 |
Yes |
| Pathology (details) | Any primary tumor with suspicion of SARS-CoV-2 infection |
| Scientific investigator(s) (Contact) | |
| Name of the director | ASSAAD |
| Surname | Souad |
| Organization | Centre Léon Bérard |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | Big pharma and ANR Flash COVID |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Centre Léon Bérard |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Others |
| Specify | Clinical database |
| Database objective | |
| Main objective |
The primary objective is to describe the mortality of cancer patients under active anticancer treatment who underwent diagnostic procedures (positive or negative) for a suspicion of COVID-19.
The primary endpoint will be the mortality rate, defined as the proportion of patients who are dead 28 days after the date of the diagnostic procedure for the 2 cohorts of patients (positive and negative). |
| Inclusion criteria |
- Confirmed diagnosis of any type of solid or hematologic tumor;
- Ongoing anticancer treatment (cytotoxic, targeted therapy, immunotherapy or loco regional procedure, including radiotherapy, surgery or interventional radiology procedure) at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure) ; - Patient with suspicion of COVID-19 (clinical symptoms of COVID-19 including fever (>38°C) and/or respiratory tract symptoms), either confirmed or not. Note 1: Patients must have underwent diagnostic procedures: diagnostic test (positive or negative) and/or chest imaging. Note 2: Patients will be eligible regardless of the presence of a neutropenia (either febrile or not) - Patient and/or family did not decline data collection after complete information (information sheet) |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | II - Neoplasms |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France (Comprehensive cancer centers, universitary hospitals and general hospitals |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2020 |
| Date of last collection (YYYY or MM/YYYY) | 2020 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1150 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Cancer history, current cancer treatments, COVID-19 diagnosis and vital status |
| Presence of a biobank |
No |
| Procedures | |
| Data collection method | Investigational sites |
| Quality procedure(s) used | Remote monitoring |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Day 28 (primary outcome and) Vital status update for all participants at the Last Patient Last Visit |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access |
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