NCT03819569

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Small Renal Mass
• Kidney Tumor

Interventions

Type	Name	Description
PROCEDURE	Small Renal Mass Biopsy	Subjects will receive a small renal mass biopsy prior to making a treatment decision
OTHER	No Small Renal Mass Biopsy	Subjects will not receive a small renal mass biopsy prior to making a treatment decision

Timeline

• Start date: 2018-10-30
• Primary completion: 2024-04-18
• Completion: 2024-04-18
• First posted: 2019-01-28
• Last updated: 2024-07-03

Locations

1 site across 1 country: United States