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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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02841020
Enrollment
0
Registered
2016-07-21
Start date
2018-06-30
Completion date
2020-03-31
Last updated
2018-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Neoplasms

Brief summary

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).

Interventions

PROCEDUREAdditional 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).

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Age 18 or greater * 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 less than 18 years of age * 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

Design outcomes

Primary

MeasureTime frame
difference in change in glomerular filtration rate (GFR)6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026