NCT02841020

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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2018

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 30, 2018

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

July 19, 2016

Last Update Submit

October 26, 2018

Conditions

Kidney Neoplasms

Outcome Measures

Primary Outcomes (1)

  • difference in change in glomerular filtration rate (GFR)

    6 months

Study Arms (2)

Control SOC

NO INTERVENTION

Standard of care is followed

Experimental additional biopsy

EXPERIMENTAL

Additional biopsy

Procedure: Additional biopsy

Interventions

Additional biopsyPROCEDURE

• 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).

Experimental additional biopsy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Urology

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 21, 2016

Study Start

June 1, 2018

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

October 30, 2018

Record last verified: 2017-11