Cancer Patients Treated With Immunotherapy in Intensive Care Unit

NCT03357861 | Completed

• 1 other identifier: 38RC17.290
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cancer; Critical Illness; Immunotherapy

Keywords

cancer; intensive care unit; checkpoint inhibitors; adverse event

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Description of the immunosuppressive treatments prescribed during the stay in intensive care for the patient's care.

  At ICU discharge (maximum 30 days)

• Description of ICU survival

  At ICU discharge (maximum 60 days)

• Description of hospital survival

  At hospital discharge (maximum 60 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Jules Bordet Institute: collaborator

Study Sites (2)

Institut Jules Bordet

Brussels, Belgium

Location

UniversityHospitalGrenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Neoplasms; Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne-Claire TOFFART, MD-PhD

  UniversityHospital Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 30, 2017
• Study Start: September 1, 2018
• Primary Completion: August 23, 2021
• Study Completion: August 23, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

FR (1); BE (1)