Cancer Patients Treated With Immunotherapy in Intensive Care Unit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-08-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer Critical Illness Immunotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Claire TOFFART, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

UniversityHospital Grenoble

Locations

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Institut Jules Bordet

Brussels, , Belgium

Site Status

UniversityHospitalGrenoble

Grenoble, , France

Site Status

Countries

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Belgium France

Other Identifiers

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38RC17.290

Identifier Type: -

Identifier Source: org_study_id