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

October 26, 2018 updated by: Noah Schenkman, MD, University of Virginia
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control SOC
Standard of care is followed
Experimental: Experimental additional biopsy
Additional biopsy
Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference in change in glomerular filtration rate (GFR)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19081 (OTHER: University of California, San Francisco)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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