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Completed

NCT Number: NCT03357861

Cancer Patients Treated With Immunotherapy in Intensive Care Unit

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.

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Key information

Conditions

Cancer Critical Illness Disease Attributes Immunotherapy Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Jules Bordet, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To evaluate the imputability of immunotherapy in the ICU admission reason for lung cancer patients treated by immunotherapy.

    Time frame: At ICU discharge (maximum 30 days)

    Description of ICU admission reason (immunotherapy toxicity versus other) for lung cancer patients treated by immunotherapy

Secondary outcomes

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

    Time frame: At ICU discharge (maximum 30 days)

    immunosuppressive treatments in intensive care unit

  2. Description of ICU survival

    Time frame: At ICU discharge (maximum 60 days)

    ICU survival

  3. Description of hospital survival

    Time frame: At hospital discharge (maximum 60 days)

    Hospital survival

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Jules Bordet Institute

Registry information

Official study title

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

Acronym: IMMUNO-REA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 30, 2017
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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