IMMUNO-REA: Cancer Patients Treated With Immunotherapy in Intensive Care Unit
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 |
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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
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Description of ICU survival [At ICU discharge (maximum 60 days)]
ICU survival
- Description of hospital survival [At hospital discharge (maximum 60 days)]
Hospital survival
Eligibility Criteria
Criteria
Inclusion Criteria:
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or = 18 years old;
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with a solid tumor;
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Treatment with anti-CTLA4 and / or anti-PD-1 / PDL-1 still in progress or up to 6 months after stopping;
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Admitted to resuscitation or continuous care in an unprogrammed way, whatever the reason.
Exclusion Criteria:
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Minors;
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Pregnant or lactating woman;
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Admission after surgery of a scheduled surgery or for the security of procedure;
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Anti-CTLA4 and / or anti-PD-1 / PDL-1 treatment stopped for more than 6 months;
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Subject under guardianship or deprivation of liberty;
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Refusal of consent;
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No affiliation to a health insurance scheme.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- 38RC17.290