Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT06020651
Status:
UNKNOWN
Last Update Posted:
2023-08-31
First Post:
2023-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vascular Toxicities of Immune ChecKpoint Inhibitors : From Bed to Benchside
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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', 'interventionModelDescription': 'All participants will undergo the same cardiovascular assessment; only cancer therapies differ according to standard of care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial dysfunction', 'timeFrame': '6 weeks', 'description': 'Surrogate marker of endothelial dysfunction : Signifiant FMD variation on ICIs as defined by the International Cardio-Oncology Society'}], 'secondaryOutcomes': [{'measure': 'Correlation of blood biomarkers to endothelial dysfunction (surrogate marker: Flow Mediated Dilatation variation)', 'timeFrame': '6 weeks', 'description': 'Increase in microparticles (CD144+, CD31+/41-, CD62e+, CD235a+, CD41+, CD11+, CD3+); cytokines (e.g., IL-1b, IFNg, TNFa, VEGF-A, C, D, HGF); single-cell profiling and deep immunophenotyping.'}, {'measure': 'Major cardiovascular event (MACE)', 'timeFrame': '6 months', 'description': 'Collection of clinically relevant MACE at clinical follow-up: acute coronary syndrome; coronary angioplasty; stroke; cardiac suddent death, myocarditis, myositis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atherosclerosis', 'Cancer', 'Immune Checkpoint Inhibitor', 'Vascular Diseases'], 'conditions': ['Renal Cell Carcinoma', 'Bladder Cancer', 'MSI-H Cancer', 'Cancer']}, 'descriptionModule': {'briefSummary': 'Immune checkpoint inhibitors (ICIs) are largely prescribed in a growing number of cancer diseases and at earlier stages (non metastatic cancer). Among immune-related adverse events, (iRAEs), the incidence of major cardiovascular events due to atherosclerosis reaches 13% at one year in patients at high risk. To the best of our knowledge, the mechanisms of this acceleration of atherosclerosis have not been studied to this date.\n\nThe VICKI study aims at furthering our knowledge on the mechanisms of atherosclerotic plaque instability by means of a prospective single-centre pilot study, by comparing:\n\n* surrogate markers of clinical vasculo-toxicity with arterial Doppler (flow mediated reserve) as defined by the International Cardio-Oncology Society;\n* circulating biomarkers\n\nBefore and after receiving ICIs for solid cancer treatment.', 'detailedDescription': 'Context. Immune checkpoint inhibitors (ICIs) are largely prescribed in a growing number of cancer diseases and at earlier stages (non metastatic cancer). Among immune-related adverse events, (iRAEs), the incidence of major cardiovascular events due to atherosclerosis reaches 13% at one year in patients at high risk. To the best of our knowledge, the mechanisms of this acceleration of atherosclerosis have not been studied to this date.\n\nEndothelial dysfunction is a predictor of the development of atherosclerotic plaque and events related to erosion or rupture. Endothelial dysfunction correlates well with the increase of circulating microparticles in various populations. The increase of circulating microparticles is also associated with major cardiovascular events.\n\nThe International society of Cardio-Oncology (IC-OS) recently published a definition for subclinical vascular toxicities due to ICIs. It includes non-invasive imaging methods readily available at the bedside (Herrmann et al. European Heart Journal 2022), largely replicated in the recent European Society of Cardiology (ESC) guidelines 2022. It includes the decrease of flow mediated reserve \\<7% or hyperhemia index \\<2; or the decrease of any of these biomarkers \\> 50% from baseline.\n\nAims and Methods. The VICKI study aims at furthering our knowledge on the mechanisms of atherosclerotic plaque instability by means of a prospective single-centre pilot study, by comparing:\n\n* surrogate markers of clinical vasculo-toxicity with arterial Doppler (flow mediated reserve, hyperhemia index, plaque volume) as defined by IC-OS;\n* circulating microparticles; Before and after receiving ICIs for solid cancer treatment.\n\nThe number of participants:\n\n* 40 patients receiving ICIs for solid cancer (alone or in combination of other cancer drugs);\n* 40 controls (matched by age, gender, cancer type) not treated by ICIs.\n\nDuration of participation: up to 6 weeks. Inclusion period: 12 months.\n\nPerspectives. The VICKI study may improve our understanding of the mechanisms of atherosclerosis mediated major cardiovascular events. If circulating biomarkers correlate well with Doppler surrogate markers of vascular toxicity, larger studies to refine prediction models could be undertaken. This would be a step forward personalized care for the prediction of major cardiovascular events on ICIs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients scheduled for first ICI therapy at our institution;\n* Matched controls with cancer and no ICI therapy;\n\nExclusion Criteria:\n\n* Major cardiovascular event in the past 6 months;\n* Unable to provide informed consent;\n* History of ICI therapy'}, 'identificationModule': {'nctId': 'NCT06020651', 'acronym': 'VICKI', 'briefTitle': 'Vascular Toxicities of Immune ChecKpoint Inhibitors : From Bed to Benchside', 'organization': {'class': 'OTHER', 'fullName': 'Institut Mutualiste Montsouris'}, 'officialTitle': 'Vascular Toxicities of Immune ChecKpoint Inhibitors : From Bed to Benchside', 'orgStudyIdInfo': {'id': 'CARDIO 05 2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICIs alone', 'description': 'Participants on ICIs alone', 'interventionNames': ['Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement']}, {'type': 'EXPERIMENTAL', 'label': 'ICIs + VEGF inhibitors', 'description': 'Participants on ICIs + VEGF inhibitors', 'interventionNames': ['Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement']}, {'type': 'EXPERIMENTAL', 'label': 'ICIs + chemotherapy', 'description': 'Participants on ICIs + chemotherapy', 'interventionNames': ['Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement']}, {'type': 'SHAM_COMPARATOR', 'label': 'Controls', 'description': 'Participants on other than ICIs cancer therapies', 'interventionNames': ['Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement']}], 'interventions': [{'name': 'Arterial Doppler for Flow Mediated Reserve measurement', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Blood sampling'], 'description': 'Arterial Doppler (ultrasound, no radiation, no contrast agent) and blood sampling twice for participants on ICIs', 'armGroupLabels': ['Controls', 'ICIs + VEGF inhibitors', 'ICIs + chemotherapy', 'ICIs alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mariana Mirabel, MD, PhD', 'role': 'CONTACT', 'email': 'mariana.mirabel@imm.fr', 'phone': '+33 1 56 61', 'phoneExt': '6479'}], 'facility': 'INstitut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Isabelle Sauret, MBS', 'role': 'CONTACT', 'email': 'isabelle.sauret@imm.fr', 'phone': '+33 1 56 61', 'phoneExt': '6705'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Mutualiste Montsouris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}