Randomized trial explores genomic urine test for cancer detection in hematuria patients
"It's the first randomized trial that I'm aware of in urine markers looking at standard of care versus a marker-based approach," says Yair Lotan, MD.
In this video, Yair Lotan, MD, University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center, discusses the randomized STRATA trial (NCT03988309), which is comparing the genomic urine test Cxbladder with standard of care in patients with hematuria who are being evaluated for urothelial carcinoma. The primary outcome measure for the trial is the change in cystoscopy use between the intervention and control arms when Cxbladder is incorporated into the evaluation process. Lotan also stresses in the video that there is an overall need in the field of urine biomarkers for more randomized trials like STRATA that are designed to demonstrate the real-world clinical utility of these markers.
Lotan co-chaired the session, “What is the clinical utility and potential for urine biomarkers?” at the Bladder Cancer Advocacy Network (BCAN) 2023 Think Tank.
Transcript
The randomized [STRATA] trial is on ClinicalTrials.gov (NCT03988309) and I think it’s 80% to 90% enrolled. It’s actually going to be done pretty soon. And, you know, I mention it for various reasons. We are a site at the University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center. But also, it's the first randomized trial that I'm aware of in urine markers looking at standard of care versus a marker-based approach. I want to encourage more people to do these types of trials, because that’s really the level of evidence that you need to get onto guidelines and to change patient management. Clearly, just publishing your performance over the last 20 years hasn't really led to adoption. So, you could argue that maybe there's a double standard compared to prostate markers, which also haven't necessarily done any randomized trials, but the reality is that when people sit down—and I'm on the hematuria guidelines—and look at the evidence, they [have been saying], “For us, we don't feel like it's enough to make recommendations.” But if there was a randomized trial, you can’t argue with that; that would be clear evidence of some benefit.
Transcript has been edited for clarity.
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