Renal Cortical Neoplasms Clinical Trial
Official title:
Office-based Percutaneous Ultrasound-guided Renal Biopsy
| Verified date | April 2021 |
| Source | University of California, Irvine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this research study is to create a prospectively maintained, multicenter database of patients undergoing renal biopsy for renal masses performed percutaneously (through skin), via an 18 gauge biopsy needle (.048 inches). In this database, the investigators will collect and maintain the data from the biopsy procedure. This will allow us to evaluate our experience with this procedure as well as to participate in multi-institutional collaborative studies in the future. At University of California Irvine, the investigators routinely biopsy patients with renal masses under real-time ultrasound control. Percutaneous renal biopsy under ultrasound guidance is a routine procedure performed to diagnose renal mass histopathology. The safety and efficacy of this procedure has been well documented in the literature. The indications for percutaneous renal biopsy have expanded as there has been a substantial increase in the number of renal masses that are being diagnosed, and the acceptance of percutaneous biopsy continues to expand in parallel. The biopsy procedure is part of your normal standard of care and if not being done for this research project.
| Status | Enrolling by invitation |
| Enrollment | 180 |
| Est. completion date | April 2022 |
| Est. primary completion date | April 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Must be undergoing standard percutaneous renal biopsy - Patients must be =18 years of age - Must be able to understand and render voluntary, written informed consent Exclusion Criteria: - Patients <18 years of age - Pregnant women - Coagulopathy - Active urinary tract infection |
| Country | Name | City | State |
|---|---|---|---|
| United States | Universty of California Irvine Medical Center | Orange | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Irvine | University of California, Los Angeles, University of Michigan, Vanderbilt University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tumor Characteristics | Tumor characteristics will be recorded at Baseline (from preoperative imaging) using the R.E.N.A.L. Nephrometry scoring system which captures tumor radius (R), depth within renal parenchyma (E), nearness to collecting system (N), anterior/posterior location (A) and polarity (L). | Baseline | |
| Secondary | Verbal analog pain scale | Preprocedural and postprocedure verbal analog pain scale. Verbal analog pain scale (0 to 10) will be recorded immediately after and 60 minutes after the procedure. Additional pain assessment will be performed at a follow-up visit 3 days to 3 weeks after the procedure. | Baseline, 1 hour post procedure, and 3 days - 3 weeks post-procedure |