Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-05 @ 12:49 AM
Study NCT ID:
NCT02841020
Status:
WITHDRAWN
Last Update Posted:
2018-10-30
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding for study fell through', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-26', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference in change in glomerular filtration rate (GFR)', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if biopsy for non-neoplastic renal disease for patients with a small renal mass results in greater postoperative renal function than the current standard of care (no additional biopsy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or greater\n* Scheduled for renal biopsy as part of clinical care\n* Diagnosis of small renal mass (\\< 4cm) based on imaging (CT, MRI, Ultrasound, or other)\n* Patient must provide written, informed consent for study procedures before randomization\n* Renal mass must be primarily solid (as opposed to cystic) in nature\n\nExclusion Criteria:\n\n* Patients less than 18 years of age\n* Patients who are prisoners\n* Women who are pregnant-self reported\n* Patients with Bosniak 3 or 4 cystic renal masses\n* Patients with history of renal transplantation\n* Patients with eGFR less than 30-based on review of clinical labs\n* Patients on dialysis\n* Patients with bleeding disorders'}, 'identificationModule': {'nctId': 'NCT02841020', 'briefTitle': 'The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial', 'orgStudyIdInfo': {'id': '19081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control SOC', 'description': 'Standard of care is followed'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental additional biopsy', 'description': 'Additional biopsy', 'interventionNames': ['Procedure: Additional biopsy']}], 'interventions': [{'name': 'Additional biopsy', 'type': 'PROCEDURE', 'description': '• Patients in the experimental group receive the additional biopsy for non-neoplastic disease during the same procedure before the biopsy of the renal mass (with potential for direct benefit to the patient by revealing non-neoplastic renal disease).', 'armGroupLabels': ['Experimental additional biopsy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Urology', 'investigatorFullName': 'Noah Schenkman, MD', 'investigatorAffiliation': 'University of Virginia'}}}}