Urine DNA Testing for Bladder Cancer
(UROSCOUT-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method for testing urothelial cancer, which affects the bladder and urinary tract. Instead of the usual invasive bladder exam (cystoscopy), the study examines urine tumor DNA tests. The goal is to ease patient experience, reduce costs, and assist doctors by decreasing the need for cystoscopies. It suits individuals scheduled for a cystoscopy who have not been previously diagnosed with urothelial cancer. As a Phase 2 trial, this research measures the effectiveness of urine tumor DNA tests in an initial, smaller group of participants.
What prior data suggests that this urine DNA testing is safe for diagnosing bladder cancer?
Research has shown that urine DNA testing for bladder cancer is generally easy for people to manage. The UroVysion Bladder Cancer Kit, for example, has received FDA approval to detect specific genetic changes linked to bladder cancer, confirming its safety for humans. Studies demonstrate that urine DNA tests can effectively detect bladder cancer without being invasive. By using urine samples, these tests avoid the discomfort and risks associated with procedures like cystoscopy, which involves inserting a tube through the urethra to examine the bladder.
Overall, urine DNA testing appears safe, with no major safety issues reported in the available research.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it focuses on a new method for detecting urothelial cancer using high volume urine DNA testing. Unlike traditional diagnostic methods like cystoscopy or urine cytology, which can be invasive or have limited sensitivity, this approach aims to provide a non-invasive and potentially more accurate way of identifying cancer. By analyzing DNA from urine, this technique might detect cancer-related genetic changes earlier or more reliably, potentially leading to earlier interventions and better patient outcomes.
What evidence suggests that urine DNA testing is effective for diagnosing bladder cancer?
Research shows that testing urine for DNA could be a promising method to detect bladder cancer. Studies have found that urine tumor DNA (utDNA) can accurately identify cancer cells in the bladder. In some cases, utDNA testing has detected signs of cancer that traditional methods, such as cystoscopy, might miss. This approach could reduce the need for uncomfortable procedures that are often unnecessary, as they rarely detect cancer. Overall, urine DNA testing offers a less invasive and potentially more accurate way to detect bladder cancer, improving patient experience and possibly catching cancer earlier.
Who Is on the Research Team?
Jussi Nikkola
Principal Investigator
Tampere University Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Sample Collection
Participants provide urine samples by mail for utDNA testing
Diagnostic Workup
Participants undergo diagnostic workup including utDNA testing and potential cystoscopy
Follow-up
Participants are monitored for sensitivity and specificity of diagnostic tests and adverse events
What Are the Treatments Tested in This Trial?
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tampere University Hospital
Lead Sponsor
Tampere University
Collaborator
Citations
Xpert® Bladder Cancer Detection
Five mRNA biomarkers were intensively validated for the detection of bladder cancer · The non-invasive and painless test uses voided urine samples · The test is ...
Urine-DNA Biomarkers in Detecting Bladder Cancer
Urinary DNA representative of the tumour genome provide a promising resource as a liquid biopsy for non-invasive genomic profiling of urothelial bladder cancers ...
UroVysion Bladder Cancer Kit
The UroVysion Bladder Cancer Kit (UroVysion Kit) is FDA approved and designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus.
Genomic Urine Assay for Bladder Cancer Surveillance
We analyzed the diagnostic value of a molecular urine test to detect recurrent disease in bladder cancer patients treated by (chemo)radiation.
Urine Tumor DNA to Stratify Recurrence Risk in Bladder Cancer
This study demonstrates that urine tumor DNA profiling can be used to stratify the risk of recurrence in patients after treatment with atezolizumab.
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