Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-04 @ 7:06 PM
Study NCT ID:
NCT04077359
Status:
COMPLETED
Last Update Posted:
2022-09-06
First Post:
2019-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Trial for Examining Hematuria Using Computed Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'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': 'D052878', 'term': 'Urolithiasis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'one investigator evaluates the experimental arm a second investigator evaluates the control arm without knowledge of the other'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One sample, paired, non-inferiority study with a 7.5% non-inferiority limit. Each patient undergo the experimental CT and the control CT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2019-08-30', 'studyFirstSubmitQcDate': '2019-08-30', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'accuracy for detecting urothelial cell carcinomas', 'timeFrame': 'all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year', 'description': 'the accuracy of the experimental arm will not be worse than the accuracy of the control CT by a margin of more than 7.5%'}], 'secondaryOutcomes': [{'measure': 'false negative rate', 'timeFrame': 'all examinations are evaluated immediately after the CT examination', 'description': 'The difference in false negative rates'}, {'measure': 'false positive rate', 'timeFrame': 'all examinations are evaluated immediately after the CT examination', 'description': 'The difference in false positive rates'}, {'measure': 'renal cell carcinoma detection rates', 'timeFrame': 'all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of RCC diagnosis after one year', 'description': 'The detection rates in the two arms'}, {'measure': 'Area under the curve (AUC)', 'timeFrame': 'all examinations are evaluated immediately after the CT examination', 'description': 'the difference in AUC of the two arms'}, {'measure': 'predictive values', 'timeFrame': 'all examinations are evaluated immediately after the CT examination', 'description': 'The difference in the predictive values of the two arms'}, {'measure': 'Detection or urinary calculi', 'timeFrame': 'all examinations are evaluated immediately after the CT examination', 'description': 'The difference in detection of the two arms'}, {'measure': 'Detection of Bosniak cyst', 'timeFrame': 'all examinations are evaluated immediately after the CT examination', 'description': 'The difference in detection in the two arms'}, {'measure': 'Interobserver variability', 'timeFrame': 'all examinations are evaluated immediately after the CT examination', 'description': 'The agreement and variability between primary and secondary readers'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urothelial Carcinoma', 'Renal Cell Carcinoma', 'Renal Cyst', 'Renal Stone']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with hematuria compared to the traditional four-phase CT (control).', 'detailedDescription': 'Responsible centers Oslo University Hospital, Aker. Division of Radiology and Nuclear medicine.\n\nStudy type: Prospective clinical trial\n\nStudy design: One sample paired proportion, non-inferiority study with a 7.5% non-inferiority limit.\n\nInvestigational product: One phase nephrographic CT (experimental arm) vs. Four-phase CT (control arm)\n\nObjective:The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with asymptomatic macroscopic hematuria compared to the traditional four-phase CT (control).\n\nPrimary endpoints: The difference in accuracy between the experimental- and control arm.\n\nthere will also be a secondary reading in order to asses interobserver variability for both the experimental and the control arm\n\nSample size: 250 patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic macroscopic hematuria referred to CTU before cystoscopy\n* \\>18 years old\n\nExclusion Criteria:\n\n* Symptomatic urinary tract infection relieved by antibiotics\n* Patients referred to CTU after cystoscopy\n* Cystoscopy within the last 6 months\n* Symptomatic stone disease\n* Macroscopic hematuria after recent catherization or instrumentation\n* Microscopic hematuria\n* Previous history of Urothelial cell carcinoma\n* Known staghorn calculi\n* Allergy to iodine contrast media\n* Impaired renal function (eGFR \\< 30m/min/1.73m2)\n* Unable to provide consent for any reason\n* For any reason, do not wish to participate in the study'}, 'identificationModule': {'nctId': 'NCT04077359', 'acronym': 'PROTEHCT', 'briefTitle': 'Prospective Trial for Examining Hematuria Using Computed Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Prospective Trial for Examining Hematuria Using Computed Tomography', 'orgStudyIdInfo': {'id': '2019/395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nephrographic phase CT', 'description': 'the nephrographic phase will be evaluated alone by a radiologist blinded to the remaining series', 'interventionNames': ['Diagnostic Test: CT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'gold standard', 'description': 'all series (unenhanced, corticomedullary, nephrographic and excretory phase) will be evaluated by a radiologist not involved in the experimental arm', 'interventionNames': ['Diagnostic Test: CT']}], 'interventions': [{'name': 'CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.', 'armGroupLabels': ['gold standard', 'nephrographic phase CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0524', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Erik Rud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consulting radiologist, PhD', 'investigatorFullName': 'Erik Rud', 'investigatorAffiliation': 'Oslo University Hospital'}}}}