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Genomic Testing

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

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.
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

GRADE-SRM Trial 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.

GRADE-SRM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am between 18 and 95 years old.
My kidney tumor is 7 cm or smaller, as confirmed by UNC.
I agree to provide additional biopsy samples for research.
I agree to let my surgical samples be used for research.
I am willing to have a blood test for cancer DNA.

GRADE-SRM Trial 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
+5 more

GRADE-SRM 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
343 Previous Clinical Trials
85,338 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for participants in this research?

"Affirmative, according to the information on clinicaltrials.gov this ongoing medical trial was published on October 30th 2018 and has recently been updated (March 22nd 2022). 130 patients are needed for participation at one site."

Answered by AI

Who qualifies to partake in this medical experiment?

"The study is actively searching for 130 individuals aged 18 to 95 who have been diagnosed with kidney neoplasms. To be eligible, applicants must also meet the following prerequisites: be evaluated at either UNC Urology or UNC Cancer Hospital and possess a small renal mass ≤7 cm as per cross-sectional radiologic studies; demonstrate willingness to complete patient-reported outcome questionnaires; provide permission for their surgical specimens to be used in research projects."

Answered by AI

Is the age of entry for this trial restricted to those over 50 years old?

"As stated by the requirements, potential patients must be between 18 and 95 years of age to join this clinical trial."

Answered by AI

What is the capacity of this research endeavor?

"Affirmative. According to the clinicaltrials.gov entry, this clinical trial began searching for candidates on October 30th 2018 and is still ongoing as of March 22nd 202022. The primary objective requires 130 individuals from one medical centre."

Answered by AI
~36 spots leftby Dec 2024