Chapel Hill, North Carolina 27599


Purpose:

Purpose: The purpose of this study is to evaluate the role of renal mass biopsy on decision-making for patients presenting with clinical T1 kidney tumors. This study also incorporates integrated biomarker study to compare the genomic data obtained through biopsy tissue to genomic information from surgical data.


Study summary:

Primary Objective 1. To compare the decisional conflict between patients who undergo renal mass biopsy during their evaluation for SRMs versus those who do not. 2. To validate the concordance of RNA sequencing (RNAseq) and genomic-based risk stratification molecular biomarkers between renal biopsy tissue and surgical (nephrectomy) specimen tissue. Secondary objective 1. To characterize the impact of biopsy on patient reported anxiety and uncertainty, assessment of cancer care communication, and satisfaction with cancer care.


Criteria:

Inclusion Criteria: - Ages 18 - 95 - Have a small renal mass ≤7 cm on cross-sectional radiologic study evaluated at the University of North Carolina (UNC) Urology or the UNC Cancer Hospital. - Has voluntarily provided signed informed consent to participate and HIPAA authorization for release of personal health information - Willing and able to complete patient-reported outcome questionnaires - Willing to have extra cores taken for research during standard of care biopsy procedure - Willing to allow surgical specimens to be used for research - Willing to undergo a blood draw to evaluate for circulating tumor DNA Exclusion Criteria - Has staging information indicating locally advanced or metastatic disease. - Presence of transplant kidney - Unwilling or unable to complete informed consent


NCT ID:

NCT03819569


Primary Contact:

Shannon L Myers
Phone: 919-966-6604
Email: shannon_myers@med.unc.edu


Backup Contact:

Email: kp@med.unc.edu
Kathryn M Pietrosimone, PhD
Phone: 919-445-6375


Location Contact:

Chapel Hill, North Carolina 27599
United States

Kathryn M Pietrosimone, PhD
Phone: 919-445-6375
Email: kp@med.unc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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