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Genomic Testing

Biopsy Decision-Making for Kidney Tumors (GRADE-SRM Trial)

N/A
Waitlist Available
Led By Hung J Tan, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Must not have
Presence of transplant kidney
Unwilling or unable to complete informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial looks at whether biopsying small kidney tumors helps doctors make decisions about treatment, and also compares genomic information from biopsied tissue to information from surgery.

Who is the study for?
This trial is for adults aged 18-95 with small kidney tumors (≤7cm) who can consent to the study and complete questionnaires. Participants must be willing to provide extra tissue during a standard biopsy, allow their surgical samples to be used for research, and have a blood draw for DNA analysis.Check my eligibility
What is being tested?
The GRADE-SRM study is comparing decision-making outcomes in patients with clinical T1 kidney tumors when they receive a renal mass biopsy versus no biopsy at all. It also examines genomic data from both biopsy tissues and surgical specimens.See study design
What are the potential side effects?
Since this trial involves biopsies and potential surgeries, common side effects may include pain at the biopsy site, bleeding, infection risk, or complications related to surgery if it occurs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 95 years old.
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My kidney tumor is 7 cm or smaller, as confirmed by UNC.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a transplanted kidney.
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I am willing and able to give informed consent.
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My cancer has spread beyond its original location.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Decisional Conflict
Genomic mutations comparison
Receipt of nephrectomy
Secondary outcome measures
Patient reported assessment of communication in cancer care
Patient-Reported Risk Perception
Anxiety
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BiopsyActive Control1 Intervention
Subjects receive a renal cell biopsy prior to making a decision about treatment
Group II: No BiopsyPlacebo Group1 Intervention
Subjects do not receive a renal cell biopsy prior to making a decision about treatment

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
354 Previous Clinical Trials
91,193 Total Patients Enrolled
Hung J Tan, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

Media Library

Small Renal Mass Biopsy (Genomic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT03819569 — N/A
Renal Masses Research Study Groups: Biopsy, No Biopsy
Renal Masses Clinical Trial 2023: Small Renal Mass Biopsy Highlights & Side Effects. Trial Name: NCT03819569 — N/A
Small Renal Mass Biopsy (Genomic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03819569 — N/A
~18 spots leftby Dec 2024
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