Kidney Cancer Clinical Trial

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

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.

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Full Description

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.

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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.

Study is for people with:

Kidney Cancer

Estimated Enrollment:

265

Study ID:

NCT03819569

Recruitment Status:

Active, not recruiting

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There is 1 Location for this study

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UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States

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Study is for people with:

Kidney Cancer

Estimated Enrollment:

265

Study ID:

NCT03819569

Recruitment Status:

Active, not recruiting

Sponsor:


UNC Lineberger Comprehensive Cancer Center

How clear is this clinincal trial information?

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