GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses — GRADE-SRM  

Kidney Tumor Clinical Trial

Official title: GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Kidney Neoplasms
• Kidney Tumor
• Small Renal Mass

• NCT number: NCT03819569
• Study type: Interventional
• Source: UNC Lineberger Comprehensive Cancer Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 30, 2018
• Completion date: December 30, 2025