Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT06548867
Status:
RECRUITING
Last Update Posted:
2024-08-12
First Post:
2024-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558660', 'term': 'cabozantinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genomic profiling', 'timeFrame': '12 months', 'description': 'to describe genomic profiling of patients with mRCC who are long-lasting responders (PFS ≥9 months) to cabozantinib and describe genomic profiling of patients with rapid disease progression following cabozntinib therapy (PFS≤ 3 months)'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '12 months', 'description': 'to describe OS based according to detected genomic profiling'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': '12 months', 'description': 'to describe ORR according to the detected genomic profiling'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '12 months', 'description': 'to describe duration of response (DOR) according to the detected genomic profilingto describe the genomic profiling according to treatment line (second, third or subsequent) to describe anamnestic characteristics (weight, ECOG PS, sites of metastasis, response to previous treatment lines)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic Renal Cell Carcinoma', 'Genomic signature', 'long lasting response', 'cabozantinib treatment'], 'conditions': ['Metastatic Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'CABOGEN is a Observational, retrospective, multicenter study that will enroll patients with metastatic clear cell renal carcinoma (mccRCC) treated with cabozantinib after one or more previous lines of treatment that included TKIs, immune checkpoint inhibitors or mTOR inhibitors.', 'detailedDescription': 'The aim of this study is to describe the genomic profiling of patients with metastatic renal cell carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment.\n\nThe study plan to enroll about 80 patients in 10 Italian centers:\n\nGroup A: 40 patients defined as long-lasting responders (PFS ≥ 9 months) Group B: 40 patients defined as primary refractories to cabozantinib (PFS ≤ 3 months)\n\nTissue samples from nephrectomy or from a metastatic site will be used to perform genomic profiling not older than 5 years.Tissue should be formalin-fixed, paraffin-embedded (FFPE).\n\nGenomic profiling will be performed with a hybrid capture-based next-generation sequencing assay (FoundationONE). The sample will be assayed for all coding exons of 324 cancer-related genes plus select introns from 34 genes that are frequently rearranged in cancer. Sequencing will be performed to a mean exon coverage depth of \\>500X. The resulting sequences will be analyzed for all classes of genomic alteration, including short variant alterations, copy number alterations, and selected gene fusions or rearrangements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with metastatic clear cell renal carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment. Cabozantinib treatment receive after one or more previuos therapy for mRCC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients with histological diagnosis of predominantly clear cell carcinoma\n* Availability of the tumor tissue from the primary tumor and/or a metastatic site for the genomic profiling analysis not older than 5 years.\n* Evaluable disease according to RECIST criteria v 1.1\n* Treatment with cabozantinib after one or more previous therapies for mRCC\n* Patient progressed from the start to cabozantinib therapy within 3 months or after 9 months\n* Any prognosis group according to the IMDC risk score\n* Signed informed consent must be obtained for living patients. Patients who died and patient untraceable will be analyzed based on the Authorization no. 9/2016 of the Italian Data Protector Supervisor.\n\nExclusion Criteria:\n\n* Non-availability of tumor tissue from the primary tumor or a metastatic site for biomarker analysis\n* Patient progressed between 3 and 9 months from the beginning of treatment with cabozantinib.\n* Non-availability of clinical information useful to evaluate the IMDC risk group at baseline.'}, 'identificationModule': {'nctId': 'NCT06548867', 'acronym': 'CABOGEN', 'briefTitle': 'Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib', 'organization': {'class': 'OTHER', 'fullName': 'Gruppo Oncologico Italiano di Ricerca Clinica'}, 'officialTitle': 'Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib: a GENomic Signature for Describing Long-lasting Response', 'orgStudyIdInfo': {'id': 'GOIRC-08-2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A: long-lasting responders', 'description': 'Patient long-lasting responders (PFS ≥9 months) to cabozantinib', 'interventionNames': ['Drug: Cabozantinib']}, {'label': 'Group B: primary refractories', 'description': 'Patient progressed from the start to cabozantinib therapy within 3 months', 'interventionNames': ['Drug: Cabozantinib']}], 'interventions': [{'name': 'Cabozantinib', 'type': 'DRUG', 'description': 'Patients must have been treated with cabozantinib after one or more previous therapies for mRCC, as per clinical practise.', 'armGroupLabels': ['Group A: long-lasting responders', 'Group B: primary refractories']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42123', 'city': 'Reggio Emilia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carmine Pinto, MD', 'role': 'CONTACT', 'email': 'carmine.pinto@ausl.re.it', 'phone': '+39 0522296614'}], 'facility': 'AUSL-IRCCS of Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'centralContacts': [{'name': 'Carmine Pinto, MD', 'role': 'CONTACT', 'email': 'carmine.pinto@ausl.re.it', 'phone': '+39 0522296614'}], 'overallOfficials': [{'name': 'Carmine Pinto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AUSL/IRCCS of Reggio Emilia'}, {'name': 'Cristina Masini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AUSL/IRCCS of Reggio Emilia'}, {'name': 'Stefania Di Girolamo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AUSL/IRCCS of Reggio Emilia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gruppo Oncologico Italiano di Ricerca Clinica', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yghea', 'class': 'UNKNOWN'}, {'name': 'Ipsen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}