Status:
COMPLETED
GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Small Renal Mass
Kidney Tumor
Eligibility:
All Genders
18-95 years
Phase:
NA
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 bioma...
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 ...
Eligibility Criteria
Inclusion
- 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 the release of personal health information
- Willing and able to complete patient-reported outcome questionnaires
- Willing to have extra cores taken for research during the 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
- Previous biopsy of small renal mass.
Exclusion
Key Trial Info
Start Date :
October 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2024
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT03819569
Start Date
October 30 2018
End Date
April 18 2024
Last Update
July 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599