Urothelial Carcinoma
Conditions
Keywords
Urothelial neoplasms, Bladder neoplasms, Upper tract urothelial neoplasms, Liquid biopsies, Urine tumor DNA
Brief summary
Urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and 600,000 diagnoses annually worldwide. The most common presenting symptom is hematuria (blood in urine), triggering a cascade of tests, including an invasive examination of the bladder using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis. The UROSCOUT-1 trial is a prospective multicenter observational study that explores the potential of urine tumor DNA (utDNA) testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. The goal is to enhance patient quality of life, reduce healthcare costs, and address increased workloads in urology centers. Sample collection will be conducted by mail, and the samples will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with cancer. Random subsampling will be applied to cancer-negative patients to achieve an approximate 1:1 ratio between cancer-positive and -negative patients.
Interventions
None listed
Sponsors
Tampere University
Tampere University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide informed consent * Patient has been scheduled for cystoscopy to rule out urothelial cancer
Exclusion criteria
* Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection | 1 year after diagnostic workup | Sensitivity and specificity of utDNA test for urothelial cancer detection, using histologically confirmed cancer diagnoses within 1 year of the diagnostic workup as ground truth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of urine cytology for urothelial cancer detection | 1 year after diagnostic workup | Sensitivity and specificity or urine cytology for urothelial cancer detection, using histologically confirmed cancer diagnoses within 1 year of the diagnostic workup as ground truth |
| Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy | 2, 5, and 10 years after diagnostic utDNA testing | Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy |
| Adverse event rate for cystoscopy | 4 weeks after cystoscopy | Adverse event rate for cystoscopy, based on CTCAE 5.0 |
| Technical success rate of utDNA test | Immediately after utDNA sample analysis | Fraction of all analyzed urine samples for which the analysis met the quality control criteria for a technically successful analysis |
| Estimate of diagnostic cystoscopies avoided | 4 weeks after cystoscopy | Estimated fraction of diagnostic cystoscopies that could have been avoided by pre-screening patients with a utDNA test (calculated as the fraction of all diagnostic utDNA samples that were negative and for which subsequent cystoscopy did not lead to clinical interventions) |
| Specificity of high-stringency utDNA threshold | 1 year after diagnostic workup | Specificity of a high-stringency utDNA threshold (at least 2 known urothelial cancer driver mutations with allele fraction \> 5%) for clinically detectable urothelial cancer |
| Sensitivity and specificity of cystoscopy for urothelial cancer detection | 1 year after diagnostic workup | Sensitivity and specificity of cystoscopy for urothelial cancer detection, using histologically confirmed cancer diagnoses within 1 year of the diagnostic workup as ground truth |
Other
| Measure | Time frame | Description |
|---|---|---|
| Characteristics of urothelial cancers that were not detected by the utDNA test | Immediately after pathological examination of surgical tissue | Characteristics of urothelial cancers that were not detected by the utDNA test (TNM pathological stage, World Health Organization (WHO) 2004/2016 grade, and tumor size) |
| Concordance between utDNA and urine cytology results | Immediately after completion of utDNA analysis and urine cytology | Concordance between utDNA and urine cytology results, with respect to positivity of the test |
Countries
Canada, Finland, Japan, United States
Contacts
Primary ContactJussi Nikkola, MD PhD
Outcome results
None listed