CancerIMMUNO-REANCT03357861
Cancer Patients Treated With Immunotherapy in Intensive Care Unit
An observational study of Cancer and Critical Illness, run by University Hospital, Grenoble at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Critical Illness, Immunotherapy
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2018to 23 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- > 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Characteristics and Care of Solid Tumor Patients Treated With Immunotherapy Admitted 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.
Read the 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.
- Conditions
- Cancer, Critical Illness, Immunotherapy
- Keywords
- cancer, intensive care unit, checkpoint inhibitors, adverse event
- Medical subject headings
- Neoplasms, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
immunosuppressive treatments in intensive care unit
Measured: At ICU discharge (maximum 30 days)
Description of ICU survival
ICU survival
Measured: At ICU discharge (maximum 60 days)
Description of hospital survival
Hospital survival
Measured: At hospital discharge (maximum 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Sep 2018
- Primary completion23 Aug 2021
- Study completion23 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Jules Bordet Institute
- Responsible party
- Sponsor
- Investigators
- Anne-Claire TOFFART, MD-PhD, Principal investigator, UniversityHospital Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357861
- Sponsor's protocol ID
- 38RC17.290
- Acronym
- IMMUNO-REA
- Status last verified
- Oct 2021
- First submitted
- 17 Nov 2017
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Care of Solid Tumor Patients Treated With Immunotherapy Admitted in Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT03357861
- Acronym / sponsor ID
- IMMUNO-REA / 38RC17.290
- Conditions
- Cancer, Critical Illness, Immunotherapy
- Keywords
- cancer, intensive care unit, checkpoint inhibitors, adverse event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Jules Bordet Institute
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- > 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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)
Description of ICU survival
Time frame: At ICU discharge (maximum 60 days)
Description of hospital survival
Time frame: At hospital discharge (maximum 60 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Claire TOFFART, MD-PhD principal investigator
UniversityHospital Grenoble
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Critical Illness, run by University Hospital, Grenoble at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.