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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03357861
Recruitment Status : Enrolling by invitation
First Posted : November 30, 2017
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
Jules Bordet Institute
Information provided by (Responsible Party):
University Hospital, Grenoble

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
Cancer Critical Illness Immunotherapy

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.

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Study Type : Observational
Estimated 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 : September 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021



Primary Outcome Measures :
  1. To evaluate the imputability of immunotherapy in the ICU admission reason for lung cancer patients treated by immunotherapy. [ Time Frame: 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. [ Time Frame: At ICU discharge (maximum 30 days) ]
    immunosuppressive treatments in intensive care unit

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

  3. Description of hospital survival [ Time Frame: At hospital discharge (maximum 60 days) ]
    Hospital survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cancer patients treated with anti-CTLA4 and/or anti-PD-1 / anti-PD-L1 or up to 6 months after stopping admitted in ICU
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357861


Locations
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Belgium
Institut Jules Bordet
Bruxelles, Belgium
France
UniversityHospitalGrenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Jules Bordet Institute
Investigators
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Principal Investigator: Anne-Claire TOFFART, MD-PhD UniversityHospital Grenoble
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03357861    
Other Study ID Numbers: 38RC17.290
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
cancer
intensive care unit
checkpoint inhibitors
adverse event
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes