Cancer Patients Treated With Immunotherapy in Intensive Care Unit

Completed

• Conditions: Cancer; Immunotherapy; Critical Illness

• Registration Number: NCT03357861
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-24
• Study First Posted: 2017-11-30
• Study Start: 2018-09-01
• Primary Completion: 2021-08-23
• Study Completion: 2021-08-23
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Description of ICU survival	At ICU discharge (maximum 60 days)	ICU survival
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 hospital survival	At hospital discharge (maximum 60 days)	Hospital survival

Trial Locations

Locations (2)

UniversityHospitalGrenoble; 🇫🇷 Grenoble, France

Institut Jules Bordet; 🇧🇪 Bruxelles, Belgium