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
NCT ID: NCT02841020
Last Updated: 2018-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-06-30
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Control SOC
Standard of care is followed
No interventions assigned to this group
Experimental additional biopsy
Additional biopsy
Additional biopsy
• 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).
Interventions
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Additional biopsy
• 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).
Eligibility Criteria
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Inclusion Criteria
* Scheduled for renal biopsy as part of clinical care
* Diagnosis of small renal mass (\< 4cm) based on imaging (CT, MRI, Ultrasound, or other)
* Patient must provide written, informed consent for study procedures before randomization
* Renal mass must be primarily solid (as opposed to cystic) in nature
Exclusion Criteria
* Patients who are prisoners
* Women who are pregnant-self reported
* Patients with Bosniak 3 or 4 cystic renal masses
* Patients with history of renal transplantation
* Patients with eGFR less than 30-based on review of clinical labs
* Patients on dialysis
* Patients with bleeding disorders
18 Years
85 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Noah Schenkman, MD
Associate Professor of Urology
Other Identifiers
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19081
Identifier Type: -
Identifier Source: org_study_id
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