Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT05621850
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2022-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2022-10-28', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood concentrations of cytokines of the innate immune response', 'timeFrame': 'Hour 0 and Hour 6', 'description': 'Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g) of the innate immune response between patients who underwent a cerebral AVM embolization procedure with patients who underwent a cerebral aneurysm embolization procedure between the expected peak at H6 and H0'}], 'secondaryOutcomes': [{'measure': 'blood concentrations of cytokines of adaptive and innate immune response', 'timeFrame': 'Hour 0 and Hour 24', 'description': 'Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g) of adaptive and innate immune response between patients with cerebral AVM embolization procedures and brain aneurysms embolization'}, {'measure': 'blood concentrations of cytokines', 'timeFrame': 'Hour 6', 'description': 'Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g)according to the duration of the embolization procedure at H6'}, {'measure': 'blood concentrations of cytokines of adaptive immune response', 'timeFrame': 'Hour 0 and Hour 6', 'description': 'Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g)of adaptive immune response between patients with cerebral AVM embolization procedures and brain aneurysms embolization between the expected peak at H6 and H0'}, {'measure': 'blood concentrations of cytokines according to the volume of embolizing agent', 'timeFrame': 'Hour 0 and Hour 6', 'description': 'Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g)according to the volume of embolizing agent'}, {'measure': 'blood concentrations of cytokines according to the embolizing agent', 'timeFrame': 'Hour 0 and Hour 6', 'description': 'Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g)according to the embolizing agent used during the procedure'}, {'measure': 'Cortisol production', 'timeFrame': 'Hour 0 and Hour 6', 'description': 'Comparison of cortisol levels before and after AMV embolization procedure'}, {'measure': 'lymphocyte subpopulations differences', 'timeFrame': 'Hour 24 and Hour 0', 'description': 'Measurement of differences in lymphocyte subpopulations in patients with cAVM embolization procedure and cerebral aneurysm between the expected peak H24 and H0 in 10 patients in each arm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arterio-venous malformation', 'DMSO', 'Immune response', 'Cytokines'], 'conditions': ['Cerebral Arterio-venous Malformation']}, 'descriptionModule': {'briefSummary': "In our ICU, it could notice that patients with cerebral arterio-venous malformation (AVM) treated with embolization develop more severe Ventilator Associated Pneumoniae (VAP) compare to other patients hospitalized for neurological diseases. The Dimethylsulfoxyde (DMSO), the solvent of the embolization implant, is known to have immune effect on vitro analysis. The investigator want to prove that exposition to embolization implant for a cerebral AMV modify the cytokines production involved the system immune's regulation.", 'detailedDescription': "Cerebral AVM are defined by abnormal connections between arteries and veins. For treatment of this vascular malformation, embolization is the gold standard. Embolization agent is made with vinylic alcohol ethylene (EVOH) copolymer which (the embolization implant) and the DMSO which is the solvent. During the injection of the product, DMSO dissipates in the bloodstream, and the EVOH precipitates and forms the embolus. It knows that DMSO had in-vitro immune effect (inhibits signalizations ways of innate and acquired immune response, decrease of pro-inflammatory cytokines production and decrease INF-γ and TNF-α production). DMSO could decrease activation and recruitment of leukocytes, which could expose patients to an increased risk of infection.\n\nThe investigator will dose cytokines in 3 blood samples (preoperative, H+6 and H+24) in planned patient's hospitalized for cerebral AVM embolization. The cytokine content of the plasmas will be analyzed with multiplex ELISA technic"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult hospitalized for a planned cerebral embolization\n\nExclusion Criteria:\n\n* Immunosuppressed patient or immunosuppressive treatment (corticosteroid included)\n* Patient with auto-immune disease\n* Hospitalization in ICU or for a planned or emergency surgery in the past three months\n* Hospitalization for an active infection in the past three months\n* Pregnancy\n* Patients requiring steroid therapy to prevent postoperative nausea and/or vomiting'}, 'identificationModule': {'nctId': 'NCT05621850', 'acronym': 'PROCESS', 'briefTitle': 'Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response', 'orgStudyIdInfo': {'id': '87RI22_0030 (PROCESS)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cerebral AVM embolization', 'interventionNames': ['Other: Blood sample']}, {'type': 'OTHER', 'label': 'cerebral aneurism embolization', 'interventionNames': ['Other: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'description': 'Based on supplementary blood sampled before embolization procedure and 6 hours and 24 hours after we will be analyzed cytokines concentration (Elisa test) and cortisol', 'armGroupLabels': ['cerebral AVM embolization', 'cerebral aneurism embolization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87042', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas DAIX, MD', 'role': 'CONTACT', 'email': 'thomas.daix@chu-limoges.fr'}, {'name': 'Thomas DAIX, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Limoges University Hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'centralContacts': [{'name': 'Thomas DAIX, MD', 'role': 'CONTACT', 'email': 'thomas.daix@chu-limoges.fr', 'phone': '555066983', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}