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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

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. ;

Study Design

Related Conditions & MeSH terms

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