Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection

Cancer Clinical Trial

— ONCOVID-19  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363632
• Other study ID #: ET20-069
• Status: Completed
• Start date: April 2, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2020
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1231
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Infection
• Sars-CoV2

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux
France	Centre François Baclesse	Caen
France	Centre Hospitalier Métropole Savoie	Chambéry
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Georges François Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	CH Annecy-Genevois	Metz-Tessy
France	Groupement Hospitalier Porte de Provence	Montélimar
France	Institut de Cancérologie de Montpellier	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Centre Hospitalier Lyon-Sud	Pierre-Bénite
France	Institut Jean Godinot	Reims
France	Centre Henri Becquerel	Rouen
France	Institut de Cancérologie de l'Ouest	Saint-Herblain
France	Institut de cancérologie Strasbourg Europe (ICANS)	Strasbourg
France	Institut Universitaire du Cancer de Toulouse - IUCT Oncopole	Toulouse
France	CH Valence	Valence

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality of cancer patients under active anticancer treatment	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).	28 days after the date of the diagnostic procedure
Secondary	Overall survival	Overall survival will be defined as the time from the date of the first diagnostic procedure (either diagnostic test or chest imaging) to the date of death due to any cause.	6 months (i.e. at the the time of last patient last visit)
Secondary	Hospitalizations	The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)	28 days after the date of the diagnostic procedure
Secondary	Death	Cause of death, related or not to the COVID-19	6 months (i.e. at the the time of last patient last visit)
Secondary	Complications	Associated complications described by their type	28 days after the date of the diagnostic procedure
Secondary	Hospitalizations	proportion of hospitalizations	28 days after the date of the diagnostic procedure
Secondary	Patients' characteristics	To describe accurately patients' characteristics in terms of demographics	At the date of the diagnostic procedure
Secondary	Patients' characteristics	To describe accurately patients' characteristics in type of tumor	At the date of the diagnostic procedure
Secondary	Patients' characteristics	To describe accurately patients' characteristics in type of anticancer treatment,	At the date of the diagnostic procedure
Secondary	Patients' characteristics	To describe accurately patients' characteristics in terms of comorbidities	At the date of the diagnostic procedure