Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection (ONCOVID-19)

June 30, 2020 updated by: Centre Leon Berard
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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Institut Bergonie
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Chambéry, France, 73011
        • Centre Hospitalier Metropole Savoie
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Lille, France, 59020
        • Centre OSCAR LAMBRET
      • Lyon, France, 69373
        • Centre Leon Berard
      • Metz-Tessy, France, 74370
        • CH Annecy-Genevois
      • Montpellier, France, 34298
        • Institut de Cancérologie de Montpellier
      • Montélimar, France, 26216
        • Groupement Hospitalier Porte de Provence
      • Nice, France
        • Centre Antoine Lacassagne
      • Pierre-Bénite, France, 69495
        • Centre hospitalier Lyon-Sud
      • Reims, France, 51726
        • Institut Jean Godinot
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint-Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest
      • Strasbourg, France, 67033
        • Institut de cancerologie Strasbourg Europe (ICANS)
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer de Toulouse - IUCT Oncopole
      • Valence, France
        • Ch Valence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with cancer in active phase of treatment suspected or diagnosed of a SARS-CoV-2 infection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality of cancer patients under active anticancer treatment
Time Frame: 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).
28 days after the date of the diagnostic procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 1, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET20-069

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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