An observational study in Cancer, Critical Illness and Immunotherapy, sponsored by University Hospital, Grenoble. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-26.
Sponsored by University Hospital, Grenoble · Observational
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.
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.
10,822 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 100 is below the median of 200 across 2,641 observational studies indexed under Neoplasms.
Browse Neoplasms studies →University Hospital, Grenoble is the lead sponsor of 838 studies on the registry; 208 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cancer patients treated with anti-CTLA4 and/or anti-PD-1 / anti-PD-L1 or up to 6 months after stopping admitted in ICU
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: At ICU discharge (maximum 30 days)
Description of the immunosuppressive treatments prescribed during the stay in intensive care for the patient's care.
immunosuppressive treatments in intensive care unit
Time frame: At ICU discharge (maximum 30 days)
Description of ICU survival
ICU survival
Time frame: At ICU discharge (maximum 60 days)
Description of hospital survival
Hospital survival
Time frame: At hospital discharge (maximum 60 days)
Ran from Sep 2018 to primary completion in Aug 2021, 35 months.
Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's 35 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble →