CompletedNot Applicable

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

United States265 participantsStarted 2018-10-30

Plain-language 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.

Who can participate

Age range18 Years – 95 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Decisional Conflict

Timeframe: Baseline, 1-3 months (before treatment)

Receipt of nephrectomy

Timeframe: 1-3 months (index treatment), 2 years

Genomic mutations comparison

Timeframe: 2 years

Trial details

NCT IDNCT03819569

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-18

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