Clinical trial · Interventional
GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
NCT03819569CI-TRIAL-00078462GRADE-SRMcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Tumor | Kidney Neoplasm | ALIAS | 0.90 |
| Small Renal Mass | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Small Renal Mass Biopsy | Other | — | UNRESOLVED |
| Small Renal Mass Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Biopsy
- description
- Subjects receive a renal cell biopsy prior to making a decision about treatment
- interventionNames
- Procedure: Small Renal Mass Biopsy
- type
- SHAM_COMPARATOR
- label
- No Biopsy
- description
- Subjects do not receive a renal cell biopsy prior to making a decision about treatment
- interventionNames
- Other: No Small Renal Mass Biopsy
Primary outcomes (3)
- measure
- Change in Decisional Conflict
- timeFrame
- Baseline, 1-3 months (before treatment)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFeinberg A, Gessner KH, Deal AM, Heiling HM, Myers S, Raynor MC, Milowsky MI, Wobker SE, Commander CW, Lazard AJ, Bjurlin MA, Smith AB, Johnson DC, Wallen EM, Kim WY, Tan HJ. Decisional Conflict Among Patients Newly Diagnosed With Clinical T1 Renal Masses: A Prospective Study. J Urol. 2024 Aug;212(2):320-330. doi: 10.1097/JU.0000000000004023. Epub 2024 May 8. PMID 38717916