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

Sponsor
Centre Leon Berard (Other)
Overall Status
Completed
CT.gov ID
NCT04363632
Collaborator
(none)
1,231
Enrollment
18
Locations
2.9
Actual Duration (Months)
68.4
Patients Per Site
23.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1231 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    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
    Actual Study Start Date :
    Apr 2, 2020
    Actual Primary Completion Date :
    Jun 30, 2020
    Actual Study Completion Date :
    Jun 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Hospitalizations [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)

    3. Death [6 months (i.e. at the the time of last patient last visit)]

      Cause of death, related or not to the COVID-19

    4. Complications [28 days after the date of the diagnostic procedure]

      Associated complications described by their type

    5. Hospitalizations [28 days after the date of the diagnostic procedure]

      proportion of hospitalizations

    6. Patients' characteristics [At the date of the diagnostic procedure]

      To describe accurately patients' characteristics in terms of demographics

    7. Patients' characteristics [At the date of the diagnostic procedure]

      To describe accurately patients' characteristics in type of tumor

    8. Patients' characteristics [At the date of the diagnostic procedure]

      To describe accurately patients' characteristics in type of anticancer treatment,

    9. Patients' characteristics [At the date of the diagnostic procedure]

      To describe accurately patients' characteristics in terms of comorbidities

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Bergonié Bordeaux France
    2 Centre François Baclesse Caen France 14076
    3 Centre Hospitalier Métropole Savoie Chambéry France 73011
    4 Centre Jean Perrin Clermont-Ferrand France 63011
    5 Centre Georges François Leclerc Dijon France 21079
    6 Centre Oscar Lambret Lille France 59020
    7 Centre Leon Berard Lyon France 69373
    8 CH Annecy-Genevois Metz-Tessy France 74370
    9 Institut de Cancérologie de Montpellier Montpellier France 34298
    10 Groupement Hospitalier Porte de Provence Montélimar France 26216
    11 Centre Antoine Lacassagne Nice France
    12 Centre Hospitalier Lyon-Sud Pierre-Bénite France 69495
    13 Institut Jean Godinot Reims France 51726
    14 Centre Henri Becquerel Rouen France 76038
    15 Institut de Cancérologie de l'Ouest Saint-Herblain France 44805
    16 Institut de cancérologie Strasbourg Europe (ICANS) Strasbourg France 67033
    17 Institut Universitaire du Cancer de Toulouse - IUCT Oncopole Toulouse France 31059
    18 CH Valence Valence France

    Sponsors and Collaborators

    • Centre Leon Berard

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Leon Berard
    ClinicalTrials.gov Identifier:
    NCT04363632
    Other Study ID Numbers:
    • ET20-069
    First Posted:
    Apr 27, 2020
    Last Update Posted:
    Jul 1, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Leon Berard
    COVID-19
    Oncology
    Epidemiology
    Predictive factors
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jul 1, 2020