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

Kidney Neoplasms 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02841020
• Other study ID #: 19081
• Status: Withdrawn
• Phase: N/A
• Start date: June 2018
• Est. completion date: March 2020

Study information

• Verified date: November 2017
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Neoplasms

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in change in glomerular filtration rate (GFR)		6 months