Ignite Creation Date:
2025-12-24 @ 11:54 AM
Ignite Modification Date:
2026-01-06 @ 2:14 PM
Study NCT ID:
NCT03357861
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer Patients Treated With Immunotherapy in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2017-11-17', 'studyFirstSubmitQcDate': '2017-11-24', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the imputability of immunotherapy in the ICU admission reason for lung cancer patients treated by immunotherapy.', 'timeFrame': 'At ICU discharge (maximum 30 days)', 'description': 'Description of ICU admission reason (immunotherapy toxicity versus other) for lung cancer patients treated by immunotherapy'}], 'secondaryOutcomes': [{'measure': "Description of the immunosuppressive treatments prescribed during the stay in intensive care for the patient's care.", 'timeFrame': 'At ICU discharge (maximum 30 days)', 'description': 'immunosuppressive treatments in intensive care unit'}, {'measure': 'Description of ICU survival', 'timeFrame': 'At ICU discharge (maximum 60 days)', 'description': 'ICU survival'}, {'measure': 'Description of hospital survival', 'timeFrame': 'At hospital discharge (maximum 60 days)', 'description': 'Hospital survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'intensive care unit', 'checkpoint inhibitors', 'adverse event'], 'conditions': ['Cancer', 'Critical Illness', 'Immunotherapy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe question of immunotherapy's imputability in the acute disease is becoming more frequent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients treated with anti-CTLA4 and/or anti-PD-1 / anti-PD-L1 or up to 6 months after stopping admitted in ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> or = 18 years old;\n* with a solid tumor;\n* Treatment with anti-CTLA4 and / or anti-PD-1 / PDL-1 still in progress or up to 6 months after stopping;\n* Admitted to resuscitation or continuous care in an unprogrammed way, whatever the reason.\n\nExclusion Criteria:\n\n* Minors;\n* Pregnant or lactating woman;\n* Admission after surgery of a scheduled surgery or for the security of procedure;\n* Anti-CTLA4 and / or anti-PD-1 / PDL-1 treatment stopped for more than 6 months;\n* Subject under guardianship or deprivation of liberty;\n* Refusal of consent;\n* No affiliation to a health insurance scheme.'}, 'identificationModule': {'nctId': 'NCT03357861', 'acronym': 'IMMUNO-REA', 'briefTitle': 'Cancer Patients Treated With Immunotherapy in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Characteristics and Care of Solid Tumor Patients Treated With Immunotherapy Admitted in Intensive Care Unit.', 'orgStudyIdInfo': {'id': '38RC17.290'}}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'UniversityHospitalGrenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Anne-Claire TOFFART, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UniversityHospital Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jules Bordet Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}