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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    130
  • sponsor
    UNC Lineberger Comprehensive Cancer Center
Updated on 25 January 2021
cancer
renal neoplasm

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.

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.

Details
Condition Malignant neoplasm of kidney, Kidney Cancer, Renal Cancer, Small Renal Mass, kidney tumor, renal tumors, neoplasia renal, renal neoplasm, renal tumor, kidney tumours, kidney tumors
Treatment Small Renal Mass Biopsy, No Small Renal Mass Biopsy
Clinical Study IdentifierNCT03819569
SponsorUNC Lineberger Comprehensive Cancer Center
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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 release of personal health information
Willing and able to complete patient-reported outcome questionnaires
Willing to have extra cores taken for research during 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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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