Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 7:34 PM
Study NCT ID:
NCT06807008
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2025-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Pathway to Detect Muscle-invasive Bladder Cancer Based on Integrated Clinical Features and VI-RADS Score on MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006417', 'term': 'Hematuria'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of the VI-RADS (Vesical Imaging-Reporting and Data System) score in predicting muscle-invasive bladder cancer (MIBC) preoperatively using MRI.', 'timeFrame': '6 weeks', 'description': 'In order to evaluate the diagnostic accuracy of the VI-RADS score in correctly differentiating non-muscle from muscle-invasive bladder disease at first diagnosis, diagnostic performance variables (sensitivity, specificity, accuracy, positive and negative predictive value, area under the curve, and ROC curves) will be calculated both overall over all participating centers and independently for different centers.\n\nThe gold standard for differential diagnosis between NMIBC and MIBC will be represented by:\n\n* TURBT in those cases then classified as low-risk NMIBC;\n* Re-TURBT in those patients who are candidates for Re-TURBT according to the guidance provided by the EAU guidelines \\[14-15\\];\n* TURBT and/or radical cystectomy in those cases classified as MIBC (≥T2).'}], 'secondaryOutcomes': [{'measure': 'The correlation between specific clinical features and MIBC.', 'timeFrame': '6 weeks', 'description': 'The correlation between specific clinical features (e.g., lesion size, presence of hydronephrosis) and MIBC. These factors were evaluated in conjunction with VI-RADS scores to refine diagnostic and predictive models'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Magnetic resonance imaging', 'VI-RADS', 'Muscle-invasive bladder cancer', 'Hematuria', 'Pathway'], 'conditions': ['Muscle Invasive Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'This study investigates the clinical, pathological, and radiological features, including the Vesical Imaging-Reporting and Data System (VI-RADS) score, that correlate with muscle-invasive bladder cancer (MIBC). It found that VI-RADS scores, along with other factors, were independent predictors of muscle invasiveness.', 'detailedDescription': 'The purpose of this study was to determine the clinical, pathological, and radiological features, including the Vesical Imaging-Reporting and Data System (VI-RADS) score, independently correlating with muscle-invasive bladder cancer (BCa), in a multicentric national setting. Patients with BCa suspicion were offered magnetic resonance imaging (MRI) before trans-urethral resection of bladder tumor (TURBT). According to VI-RADS, a cutoff of ≥ 3 or ≥ 4 was assumed to define muscle-invasive bladder cancer (MIBC). Trans-urethral resection of the tumor (TURBT) and/or cystectomy reports will be compared with preoperative VI-RADS scores to assess accuracy of MRI for discriminating between non-muscle-invasive versus MIBC. Performance will be assessed by ROC curve analysis. Two univariable and multivariable logistic regression models were implemented including clinical, pathological, radiological data, and VI-RADS categories to determine the variables with an independent effect on MIBC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This multicenter prospective observational study received formal approval from the Institutional Review Board and Ethics Committee of each participating center. All patients were informed of the experimental nature of this study and gave written informed consent. All patients with suspected BCa were referred to four different centers (Sapienza University of Rome \\[center #1\\], Istituto Nazionale Tumori "Regina Elena" in Rome \\[center #2\\], Azienda Ospedaliera Universitaria Santa Maria della Misericordia in Udine \\[center #3\\], and Azienda Ospedaliera Universitaria in Bologna \\[center #4\\]), between January 2020 and May 2021, and underwent bladder MRI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a primary diagnosis of bladder tumor,\n* positive urinary cytology,\n* suspected bladder neoplasm identifed by ultrasound of the urinary tract and/or cystoscopy and/or CT scan of the abdomen-pelvis.\n\nExclusion Criteria:\n\n* history of prior urinary tract neoplasms,\n* impossibility of achieving appropriate bladder distension,\n* concomitant diagnosis of carcinoma in situ (CIS),\n* no detectable lesion on MRI\n* any contraindication to MRI (low renal function, MR unsafe medical devices etc.)\n* any contraindication to spinal and general anesthesia.'}, 'identificationModule': {'nctId': 'NCT06807008', 'acronym': 'VI-RADS', 'briefTitle': 'A Novel Pathway to Detect Muscle-invasive Bladder Cancer Based on Integrated Clinical Features and VI-RADS Score on MRI', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'A Novel Pathway to Detect Muscle-invasive Bladder Cancer Based on Integrated Clinical Features and VI-RADS Score on MRI: Results of a Prospective Multicenter Study', 'orgStudyIdInfo': {'id': 'VI-RADS'}}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'country': 'Italy', 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Roma', 'state': 'Italy', 'country': 'Italy', 'facility': 'AOU Policlinico Umberto I - Sapienza University of Rome', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'state': 'Italy', 'country': 'Italy', 'facility': 'Regina Elena" National Cancer Institute', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Udine', 'state': 'Italy', 'country': 'Italy', 'facility': 'Santa Maria della Misericordia University Hospital in Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'overallOfficials': [{'name': 'Riccardo Schiavina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}