Clinical trial NCT04363632: Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection
Official title: Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Cancer
Keywords: COVID-19
Oncology
Epidemiology
Predictive factors
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 1231
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cancer in active phase of treatment suspected or diagnosed of a SARS-CoV-2 infection

Brief summary: National multicentre epidemiological study to describe retrospectively and prospectively the clinical outcomes of patients with a suspected coronavirus infection (either confirmed or not) while receiving a medical treatment for the underlying cancer


Eligibility criteria: Inclusion Criteria:

I1. Confirmed diagnosis of any type of solid or hematologic tumor;

I2. 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) ;

I3. 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) ;

I4. Patient and/or family did not decline data collection after complete information.

Primary outcomes:
measure: Mortality of cancer patients under active anticancer treatment
timeFrame: 28 days after the date of the diagnostic procedure
Secondary outcomes:
measure: Overall survival
timeFrame: 6 months (i.e. at the the time of last patient last visit)
measure: Hospitalizations
timeFrame: 28 days after the date of the diagnostic procedure
measure: Death
timeFrame: 6 months (i.e. at the the time of last patient last visit)
measure: Complications
timeFrame: 28 days after the date of the diagnostic procedure
measure: Hospitalizations
timeFrame: 28 days after the date of the diagnostic procedure
measure: Patients' characteristics
timeFrame: At the date of the diagnostic procedure
measure: Patients' characteristics
timeFrame: At the date of the diagnostic procedure
measure: Patients' characteristics
timeFrame: At the date of the diagnostic procedure
measure: Patients' characteristics
timeFrame: At the date of the diagnostic procedure
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre François Baclesse
city: Chambéry
country: France
facility: Centre Hospitalier Métropole Savoie
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Metz-Tessy
country: France
facility: CH Annecy-Genevois
city: Montpellier
country: France
facility: Institut de Cancérologie de Montpellier
city: Montélimar
country: France
facility: Groupement Hospitalier Porte de Provence
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-Sud
city: Reims
country: France
facility: Institut Jean Godinot
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS)
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - IUCT Oncopole
city: Valence
country: France
facility: CH Valence
Study officials:
References:
citation: Assaad S, Zrounba P, Cropet C; ONCOVID-19 study Consortium; Blay JY. Mortality of patients with solid and haematological cancers presenting with symptoms of COVID-19 with vs without detectable SARS-COV-2: a French nationwide prospective cohort study. Br J Cancer. 2021 Aug;125(5):658-671. doi: 10.1038/s41416-021-01452-4. Epub 2021 Jun 16.