Cancer Patients Treated With Immunotherapy in Intensive Care Unit

Cancer Clinical Trial

— IMMUNO-REA  

Official title:

Characteristics and Care of Solid Tumor Patients Treated With Immunotherapy Admitted in Intensive Care Unit.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357861
• Other study ID #: 38RC17.290
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: August 23, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 23, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Critical Illness
• Immunotherapy

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Bruxelles
France	UniversityHospitalGrenoble	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Jules Bordet Institute

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the imputability of immunotherapy in the ICU admission reason for lung cancer patients treated by immunotherapy.	Description of ICU admission reason (immunotherapy toxicity versus other) for lung cancer patients treated by immunotherapy	At ICU discharge (maximum 30 days)
Secondary	Description of the immunosuppressive treatments prescribed during the stay in intensive care for the patient's care.	immunosuppressive treatments in intensive care unit	At ICU discharge (maximum 30 days)
Secondary	Description of ICU survival	ICU survival	At ICU discharge (maximum 60 days)
Secondary	Description of hospital survival	Hospital survival	At hospital discharge (maximum 60 days)