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

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Kidney Tumor; Small Renal Mass

Treatments: Procedure: Small Renal Mass Biopsy; Other: No Small Renal Mass Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03819569

LCCC 1834

Details and patient eligibility

About

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.

Full 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.

Enrollment: 265 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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265 participants in 2 patient groups

Biopsy

Active Comparator group

Description:

Subjects receive a renal cell biopsy prior to making a decision about treatment

Treatment:

Procedure: Small Renal Mass Biopsy

No Biopsy

Sham Comparator group

Description:

Subjects do not receive a renal cell biopsy prior to making a decision about treatment

Treatment:

Other: No Small Renal Mass Biopsy