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

Completed

• Conditions: Sars-CoV2; Cancer

• Registration Number: NCT04363632
• Lead Sponsor: Centre Leon Berard

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-02
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-27
• Status Verified: 2020-06
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1231

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality of cancer patients under active anticancer treatment	28 days after the date of the diagnostic procedure	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).

Secondary Outcome Measures

Name	Time	Method
Hospitalizations	28 days after the date of the diagnostic procedure	proportion of hospitalizations
Patients' characteristics	At the date of the diagnostic procedure	To describe accurately patients' characteristics in terms of comorbidities
Overall survival	6 months (i.e. at the the time of last patient last visit)	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.
Death	6 months (i.e. at the the time of last patient last visit)	Cause of death, related or not to the COVID-19
Complications	28 days after the date of the diagnostic procedure	Associated complications described by their type

Trial Locations

Locations (18)

Centre Hospitalier Lyon-Sud; 🇫🇷 Pierre-Bénite, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre François Baclesse; 🇫🇷 Caen, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre Hospitalier Métropole Savoie; 🇫🇷 Chambéry, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre Leon Berard; 🇫🇷 Lyon, France

CH Annecy-Genevois; 🇫🇷 Metz-Tessy, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut de Cancérologie de Montpellier; 🇫🇷 Montpellier, France

CH Valence; 🇫🇷 Valence, France

Institut Universitaire du Cancer de Toulouse - IUCT Oncopole; 🇫🇷 Toulouse, France

Groupement Hospitalier Porte de Provence; 🇫🇷 Montélimar, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Institut de Cancérologie de l'Ouest; 🇫🇷 Saint-Herblain, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Institut de cancérologie Strasbourg Europe (ICANS); 🇫🇷 Strasbourg, France