Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT06113367
Status:
UNKNOWN
Last Update Posted:
2023-11-02
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunotherapy in Upper Tract Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-27', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-10-27', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival on anti-PD-(L)1 immunotherapy', 'timeFrame': '2 years after immunotherapy initiation'}], 'secondaryOutcomes': [{'measure': 'Best Objective Radiologic Response', 'timeFrame': 'Up to 7 years maximum', 'description': 'Evaluated by RECIST v1.1 The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard system to measure how cancer responds to different treatments.It permits to evaluate the response according to the evolution of the lesions.'}, {'measure': 'Overall survival', 'timeFrame': '5 years after immunotherapy initiation'}, {'measure': 'Progression free survival', 'timeFrame': '6 months after immunotherapy initiation'}, {'measure': 'Progression free survival', 'timeFrame': '1 year after immunotherapy initiation'}, {'measure': 'Progression free survival', 'timeFrame': '2 years after immunotherapy initiation'}, {'measure': 'Progression free survival', 'timeFrame': '3 years after immunotherapy initiation'}, {'measure': 'Duration of immunotherapy treatment', 'timeFrame': 'Up to 7 years after immunotherapy initiation', 'description': 'Treatment tolerability'}, {'measure': 'Reasons for treatment discontinuation', 'timeFrame': 'Up to 7 years after immunotherapy initiation'}, {'measure': 'Translational study of predictive biomarkers of efficacy', 'timeFrame': 'Up to 7 years after immunotherapy initiation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urothelial Carcinoma']}, 'descriptionModule': {'briefSummary': 'Upper-tract urothelial carcinoma (UTUC) is a rare tumor. Standard treatment of localized disease is most often radical nephroureterectomy.\n\nIn advanced/metastatic disease, treatments follow the standards for urothelial carcinoma including platinum-based chemotherapy and anti-PD(L)1 (Programmed death (ligand) 1) immunotherapy, with no regard as to the primary disease site (bladder or upper tract). Given the rarity of UTUC, efficacy data in the UTUC subgroup of advanced urothelial carcinoma is scarce.\n\nUTUC show distinct pahological and molecular features, including higher prevalence of microsatellite instability and of abnormalities in the FGFR (fibroblast growth factor receptors) gene family. These specific features may impact outcomes of immunotherapy in advanced/metastatic UTUC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 and more\n* Diagnosis of urothelial carcinoma (with or without variant histology)\n* Advanced/metastatic disease not amenable to local treatment with curative intent\n* Treatment with an anti-PD-(L)1 monoclonal antibody initiated between 2016 and 2022\n\nExclusion Criteria:\n\n* Patient's opposition to this research\n* Urothelial carcinoma of bladder or urethral primary site\n* Non-urothelial tumor\n* Maintenance immunotherapy initiated without disease progression"}, 'identificationModule': {'nctId': 'NCT06113367', 'acronym': 'VESUVIO', 'briefTitle': 'Immunotherapy in Upper Tract Urothelial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Carcinomes urothéliaux Des Voies excrétrices supérieures traitées en Vie réelle Par immunothérapie (VESUVIO) : étude rétrospective Nationale', 'orgStudyIdInfo': {'id': 'APHP230738'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy', 'interventionNames': ['Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy']}], 'interventions': [{'name': 'Evaluation of anti-PD-(L)1 immunotherapy efficacy', 'type': 'OTHER', 'description': 'Non Applicable, research on data', 'armGroupLabels': ['Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clément Dumont, Dr', 'role': 'CONTACT', 'email': 'clement.dumont@aphp.fr', 'phone': '+142494217'}, {'name': 'Jérôme Lambert, Pr', 'role': 'CONTACT', 'email': 'jerome.lambert@u-paris.fr', 'phone': '+33142499742'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}