GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 95 |
| Updated: | 1/30/2019 |
| Start Date: | October 30, 2018 |
| End Date: | December 30, 2023 |
| Contact: | Shannon L Myers |
| Email: | shannon_myers@med.unc.edu |
| Phone: | 919-966-6604 |
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.
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.
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.
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.
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 release of personal health information
- Willing and able to complete patient-reported outcome questionnaires
- Willing to have extra cores taken for research during 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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Principal Investigator: Hung-Jui Tan, MD, MSHPM
Phone: 919-445-6375
Click here to add this to my saved trials
