Clinical trial NCT03819569: GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
Official title: GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small Renal Mass
Kidney Tumor
Keywords: genomic risk assessment
small renal mass
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-randomized, comparative
Primary purpose: OTHER

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 biomarker study to compare the genomic data obtained through biopsy tissue to genomic information from surgical data.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Decisional Conflict
timeFrame: Baseline, 1-3 months (before treatment)
measure: Receipt of nephrectomy
timeFrame: 1-3 months (index treatment), 2 years
measure: Genomic mutations comparison
timeFrame: 2 years
Secondary outcomes:
measure: Patient-reported anxiety
timeFrame: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
measure: Patient-reported cancer worry
timeFrame: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
measure: Patient-Reported Risk Perception
timeFrame: Baseline, 1-3 months (before treatment)
measure: Patient-reported uncertainty based on Short-Form Mishel Uncertainty of Illness Scale
timeFrame: baseline, 1-3 months (before treatment)
measure: Patient-reported regret about the decision
timeFrame: 6, 12, 18, 24 months
measure: Patient-reported health-related quality of life
timeFrame: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
measure: Patient reported assessment of communication in cancer care
timeFrame: Baseline, 1-3 months (before treatment)
measure: Receipt of any intervention (ablation, radiation therapy, nephrectomy)
timeFrame: 1-3 months (index treatment), 2 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Hung J Tan, MD
role: PRINCIPAL_INVESTIGATOR
References: