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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04363632
Other study ID # ET20-069
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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