GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 2
- 主要终点
- Change in Decisional Conflict
研究概览
简要总结
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.
详细描述
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
- To characterize the impact of biopsy on patient reported anxiety and uncertainty, assessment of cancer care communication, and satisfaction with cancer care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Change in Decisional Conflict
时间窗: Baseline, 1-3 months (before treatment)
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.
Receipt of nephrectomy
时间窗: 1-3 months (index treatment), 2 years
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.
Genomic mutations comparison
时间窗: 2 years
Molecular subtype (ccA vs ccB) and the presence of genomic mutations between the renal mass biopsy and the surgical nephrectomy specimen will be compared.
次要结局
- Receipt of any intervention (ablation, radiation therapy, nephrectomy)(1-3 months (index treatment), 2 years)
- Patient-reported anxiety(Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months)
- Patient-reported cancer worry(Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months)
- Patient-reported regret about the decision(6, 12, 18, 24 months)
- Patient-Reported Risk Perception(Baseline, 1-3 months (before treatment))
- Patient-reported uncertainty based on Short-Form Mishel Uncertainty of Illness Scale(baseline, 1-3 months (before treatment))
- Patient-reported health-related quality of life(Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months)
- Patient reported assessment of communication in cancer care(Baseline, 1-3 months (before treatment))