Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-19 @ 4:43 PM
Study NCT ID:
NCT07243067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor-Derived Extracellular Vesicles for Noninvasive Molecular Classification of Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}], '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': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differentiate tumor-derived extracellular vesicle (tdEV) surface proteins expressed in benign vs malignant renal tumors', 'timeFrame': 'Baseline', 'description': 'Differential protein expression analysis will be performed on stored urine samples from a biorepository to identify tdEV proteins in each renal cell carcinoma (RCC) subtype (clear-cell, papillary, and chromophobe) versus benign.'}, {'measure': 'Prediction of metastasis after surgery', 'timeFrame': 'Perioperative (pre- and post-nephrectomy),', 'description': 'Blood samples will be collected pre-and post-nephrectomy to asses for tdEV levels which will be correlated with clinicopathological features to test whether tdEV levels can be used to better predict likelihood of metastasis in patients undergoing curative-intent radical nephrectomy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma', 'Clear-cell Renal Cell Carcinoma', 'Papillary Renal Cell Carcinoma', 'Chromophobe Renal Cell Carcinoma', 'Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'This is a correlative (lab-based) study aiming to identify protein markers in urine extracellular vesicles (EVs) that can be used to develop non-invasive molecular tests for patients with renal cell carcinoma (RCC). Aim 1 will use urine collected previously in biorepository. Aim 2 will prospectively collect blood specimens pre and post nephrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Mayo Clinic patients scheduled to undergo nephrectomy for treatment of RCC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Urine sample in existing biorepository\n* High-risk renal cell carcinoma (RCC) per American Urological Association (AUA) guidelines\n* Scheduled to undergo nephrectomy\n\nExclusion Criteria:\n\n* Does not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT07243067', 'briefTitle': 'Tumor-Derived Extracellular Vesicles for Noninvasive Molecular Classification of Kidney Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Tumor-Derived Extracellular Vesicles for Noninvasive Molecular Classification of Kidney Cancer', 'orgStudyIdInfo': {'id': '25-003121'}, 'secondaryIdInfos': [{'id': 'HT9425-25-1-0607', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clear-cell RCC', 'description': 'Participants with clear-cell RCC', 'interventionNames': ['Other: Proteomic profiling of urinary EVs', 'Procedure: Blood sample collection']}, {'label': 'Papillary RCC', 'description': 'Participants with papillary RCC', 'interventionNames': ['Other: Proteomic profiling of urinary EVs', 'Procedure: Blood sample collection']}, {'label': 'Chromophobe RCC', 'description': 'Participants with chromophobe RCC', 'interventionNames': ['Other: Proteomic profiling of urinary EVs', 'Procedure: Blood sample collection']}, {'label': 'Benign Renal Tumor', 'description': 'Participants with benign renal tumors', 'interventionNames': ['Other: Proteomic profiling of urinary EVs']}], 'interventions': [{'name': 'Proteomic profiling of urinary EVs', 'type': 'OTHER', 'description': 'EV isolation and mass spectrometry.', 'armGroupLabels': ['Benign Renal Tumor', 'Chromophobe RCC', 'Clear-cell RCC', 'Papillary RCC']}, {'name': 'Blood sample collection', 'type': 'PROCEDURE', 'description': 'Blood samples collected pre- and post-nephrectomy', 'armGroupLabels': ['Chromophobe RCC', 'Clear-cell RCC', 'Papillary RCC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Fabrice Lucien-Matteoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}], 'overallOfficials': [{'name': 'Fabrice Lucien-Matteoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}