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

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2020-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Kidney Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control SOC

Standard of care is followed

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental additional biopsy

Additional biopsy

Group Type EXPERIMENTAL

Additional biopsy

Intervention Type PROCEDURE

• 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Noah Schenkman, MD

Associate Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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19081

Identifier Type: -

Identifier Source: org_study_id

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