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

Study Overview
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Brief Summary
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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
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Primary Objective To compare the decisional conflict between patients who undergo renal mass biopsy during their evaluation for SRMs versus those who do not. 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.

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

Conditions
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Small Renal Mass, Kidney Tumor

Intervention / Treatment
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* Procedure: Small Renal Mass Biopsy
* Other: No Small Renal Mass Biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: non-randomized, comparative
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biopsy<br>Subjects receive a renal cell biopsy prior to making a decision about treatment | Procedure: Small Renal Mass Biopsy<br>* Subjects will receive a small renal mass biopsy prior to making a treatment decision<br>|
| Sham Comparator: No Biopsy<br>Subjects do not receive a renal cell biopsy prior to making a decision about treatment | Other: No Small Renal Mass Biopsy<br>* Subjects will not receive a small renal mass biopsy prior to making a treatment decision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Decisional Conflict | Decisional conflict scale between patients who undergo renal mass biopsy, and who do not will be compared. Decisional conflict scale is a validated, 16-item instrument that measures personal perceptions of decision-making. It yields a total score from 0 to 100 (higher scores indicate more decisional conflict) and sub-scores for perceptions of uncertainty, informed values clarity, support, and effectiveness in decision-making. | Baseline, 1-3 months (before treatment) | 
| Receipt of nephrectomy | The proportion of patients undergoing nephrectomy (radical and partial nephrectomy) between patients who undergo renal mass biopsy versus those who do not will be compared. | 1-3 months (index treatment), 2 years | 
| Genomic mutations comparison | Molecular subtype (ccA vs ccB) and the presence of genomic mutations between the renal mass biopsy and the surgical nephrectomy specimen will be compared. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported anxiety | Patient-reported anxiety will be assessed using the Short Form PROMIS Anxiety scale. Short Form PROMIS Anxiety is a validated 4-item survey of generalized anxiety, consisting of 5 questions, each scored using a 5-point Likert scale. High scores reflect better results. | Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months | 
| Patient-reported cancer worry | Patient-reported cancer worry will be assessed using the Brief Worry Scale which is a 4 questions assessment designed to measure the relationship between worry and an event or behavior. This study will use the brief worry scale to measure the relationship between worry and the diagnosis of a small renal mass. | Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months | 
| Patient-Reported Risk Perception | Patient-reported Risk Perception will be assessed using 2 two-question instrument to assign a numeric risk score for patients regarding incidental renal lesions, which may facilitate accurate risk comprehension. | Baseline, 1-3 months (before treatment) | 
| Patient-reported uncertainty | Patient-reported uncertainty will be assessed using the Short-Form Mishel Uncertainty of Illness Scale which is a validated instrument that measures the patient's perception of the uncertainty of symptoms, diagnosis, treatment, and prognosis as well as the uncertainty subscale of the Decisional Conflict Scale. The scores are summed to yield a total score with a higher score indicating greater uncertainty. | baseline, 1-3 months (before treatment) | 
| Patient-reported regret about the decision | Patient-reported regret about the decision will be assessed using the Decisional regret scale. Decisional Regret scale is a 5-item regret scale that measures distress or remorse after a healthcare decision. The short form consists of 5 questions, each scored using a 5-point Likert scale, indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree). | 6, 12, 18, 24 months | 
| Patient-reported health-related quality of life | Patient-reported health-related quality of life will be assessed using The PROMIS Global Health scale is an 8-item, validated survey that represents five core PROMIS domains (physical function, pain, fatigue, emotional distress, social health). Higher score indicating better quality of life. | Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months | 
| Patient reported assessment of communication in cancer care | The validated 6-item Short-Form for Patient-Centered Communication-Cancer Scale. This is a validated, 6-item instrument that measures the patient's perspective on communication in cancer care. It incorporates questions relating to exchanging information, fostering relationships, making decisions, responding to emotions, enabling self-efficacy, and managing uncertainty. Each item is scored 1-5, and the overall score is an average of 6 questions, with 5 indicating the most satisfaction. A high score indicates better communication. | Baseline, 1-3 months (before treatment) | 
| Receipt of any intervention (ablation, radiation therapy, nephrectomy) | The proportion of patients undergoing ablation, radiation therapy, nephrectomy between patients who undergo renal mass biopsy versus those who do not will be compared | 1-3 months (index treatment), 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genomic risk assessment, small renal mass