NCT03357861

Completed

Cancer Patients Treated With Immunotherapy in Intensive Care...

University Hospital, Grenoble Source

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Other study identifiers

Sponsor study identifier

38RC17.290

Study Type

observational

Actual enrollment (reported)

100

Locations

2 countries

Sites

2

Timeline

Study Start

September 1, 2018

Actual (reported)

Primary Completion

August 23, 2021

Actual (reported)

Study Completion

August 23, 2021

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 100 participants
Study completion date: August 23, 2021
Actual (reported)
Listed locations: 2 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 17, 2017
Actual (reported)
First Posted
November 30, 2017
Actual (reported)
Study Start
September 1, 2018
Actual (reported)
Primary Completion
August 23, 2021
Actual (reported)
Study Completion
August 23, 2021
Actual (reported)

Last Updated: October 26, 2021
Status Verified: October 2021
Last Update Submitted: October 25, 2021

Conditions

Cancer Critical Illness Immunotherapy

Keywords

cancerintensive care unitcheckpoint inhibitorsadverse 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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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;

Sponsors & Collaborators

Jules Bordet Institute
Othercollaborator
University Hospital, Grenoble
Otherlead

Study Sites (2)

Institut Jules Bordet

Brussels, Belgium

UniversityHospitalGrenoble

Grenoble, 38043, France

MeSH Terms

Conditions

NeoplasmsCritical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Anne-Claire TOFFART, MD-PhD
UniversityHospital Grenoble
PRINCIPAL INVESTIGATOR

Enrollment

100 participants (actual enrollment reported by the registry).

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

Actual (reported)

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Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy

Not ApplicableActive Not Recruiting

NCT03989323

A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE

Recruiting

NCT03693326

PDR001 in Patients With Non-small Cell Lung Cancer Harboring KRAS/NRAS Mutation or no Actionable Genetic Abnormalities

Phase 2Unknown

NCT03347058

Immunotherapy & Me

Not ApplicableCompleted

NCT03453814

Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit

Not ApplicableCompleted

NCT03561467

Oral Chemotherapy and Quality of Care

Unknown

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.

Contact the study team to confirm eligibility.

Primary Completion

August 23, 2021

Actual (reported)

Study Completion

August 23, 2021

Actual (reported)

Last Updated

October 26, 2021

Record last verified: 2021-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03357861
Data provider: ClinicalTrials.gov
Source updated: 2021-10-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:56 UTC

Locations

BE(1)FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations