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Withdrawn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
About this trial
This is an interventional diagnostic trial for Kidney Neoplasms
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
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
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Withdrawn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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