IMMUNO-REA: Cancer Patients Treated With Immunotherapy in Intensive Care Unit

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT03357861
Collaborator
Jules Bordet Institute (Other)
100
2
35.7
50
1.4

Study Details

Study Description

Brief Summary

This work aims to describe the characteristics and methods of management of patients suffering from a solid tumor treated with immunotherapy admitted to intensive care.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The place of checkpoint inhibitors (anti-PD-1 and PD-L-1) is currently validated in the management of melanoma and metastatic non-small cell lung cancer. The toxicity profile is specific with adverse effects related to immunity. Some side effects (myocarditis, colitis, interstitial lung disease, etc.) can be severe and patient could be hospitalized in intensive care unit.

    The question of immunotherapy's imputability in the acute disease is becoming more frequent.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Characteristics and Care of Solid Tumor Patients Treated With Immunotherapy Admitted in Intensive Care Unit.
    Actual Study Start Date :
    Sep 1, 2018
    Actual Primary Completion Date :
    Aug 23, 2021
    Actual Study Completion Date :
    Aug 23, 2021

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the imputability of immunotherapy in the ICU admission reason for lung cancer patients treated by immunotherapy. [At ICU discharge (maximum 30 days)]

      Description of ICU admission reason (immunotherapy toxicity versus other) for lung cancer patients treated by immunotherapy

    Secondary Outcome Measures

    1. Description of the immunosuppressive treatments prescribed during the stay in intensive care for the patient's care. [At ICU discharge (maximum 30 days)]

      immunosuppressive treatments in intensive care unit

    2. Description of ICU survival [At ICU discharge (maximum 60 days)]

      ICU survival

    3. Description of hospital survival [At hospital discharge (maximum 60 days)]

      Hospital survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • or = 18 years old;

    • with a solid tumor;

    • Treatment with anti-CTLA4 and / or anti-PD-1 / PDL-1 still in progress or up to 6 months after stopping;

    • Admitted to resuscitation or continuous care in an unprogrammed way, whatever the reason.

    Exclusion Criteria:
    • Minors;

    • Pregnant or lactating woman;

    • Admission after surgery of a scheduled surgery or for the security of procedure;

    • Anti-CTLA4 and / or anti-PD-1 / PDL-1 treatment stopped for more than 6 months;

    • Subject under guardianship or deprivation of liberty;

    • Refusal of consent;

    • No affiliation to a health insurance scheme.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Jules Bordet Bruxelles Belgium
    2 UniversityHospitalGrenoble Grenoble France 38043

    Sponsors and Collaborators

    • University Hospital, Grenoble
    • Jules Bordet Institute

    Investigators

    • Principal Investigator: Anne-Claire TOFFART, MD-PhD, UniversityHospital Grenoble

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT03357861
    Other Study ID Numbers:
    • 38RC17.290
    First Posted:
    Nov 30, 2017
    Last Update Posted:
    Oct 26, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Grenoble
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 26, 2021