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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

Primary Purpose

Kidney Neoplasms

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Additional biopsy
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Neoplasms

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control SOC

    Experimental additional biopsy

    Arm Description

    Standard of care is followed

    Additional biopsy

    Outcomes

    Primary Outcome Measures

    difference in change in glomerular filtration rate (GFR)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 19, 2016
    Last Updated
    October 26, 2018
    Sponsor
    University of Virginia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02841020
    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
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding for study fell through
    Study Start Date
    June 2018 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    March 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Virginia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Neoplasms

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control SOC
    Arm Type
    No Intervention
    Arm Description
    Standard of care is followed
    Arm Title
    Experimental additional biopsy
    Arm Type
    Experimental
    Arm Description
    Additional biopsy
    Intervention Type
    Procedure
    Intervention Name(s)
    Additional biopsy
    Intervention 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).
    Primary Outcome Measure Information:
    Title
    difference in change in glomerular filtration rate (GFR)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this 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

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