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Spots Global Cancer Trial Database for GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses

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Trial Identification

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

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

Study ID: NCT03819569

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Contact Details

Name: Hung J Tan, MD

Affiliation: UNC Lineberger Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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