Clinical trial NCT06310759: Prospective Validation Study of High Volume Urine DNA Testing in Individuals with Suspicion of Urothelial Cancer
Official title: Observational Prospective Multicenter Validation Study Investigating the Possibility of Replacing Cystoscopies with High Volume Urine DNA Testing in Individuals with Suspicion of Urothelial Cancer (UROSCOUT-1)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urothelial Carcinoma
Keywords: Urothelial neoplasms
Bladder neoplasms
Upper tract urothelial neoplasms
Liquid biopsies
Urine tumor DNA
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
First posted: 2024-03-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for diagnostic cystoscopy to rule out urothelial cancer due to hematuria, imaging, or urine cytology findings.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection
timeFrame: 1 year after diagnostic workup
Secondary outcomes:
measure: Sensitivity and specificity of cystoscopy for urothelial cancer detection
timeFrame: 1 year after diagnostic workup
measure: Sensitivity and specificity of urine cytology for urothelial cancer detection
timeFrame: 1 year after diagnostic workup
measure: Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy
timeFrame: 2, 5, and 10 years after diagnostic utDNA testing
measure: Adverse event rate for cystoscopy
timeFrame: 4 weeks after cystoscopy
measure: Technical success rate of utDNA test
timeFrame: Immediately after utDNA sample analysis
measure: Estimate of diagnostic cystoscopies avoided
timeFrame: 4 weeks after cystoscopy
measure: Specificity of high-stringency utDNA threshold
timeFrame: 1 year after diagnostic workup
Other outcomes:
measure: Characteristics of urothelial cancers that were not detected by the utDNA test
timeFrame: Immediately after pathological examination of surgical tissue
measure: Concordance between utDNA and urine cytology results
timeFrame: Immediately after completion of utDNA analysis and urine cytology
Locations:
city: Chicago
country: United States
facility: Jesse Brown Department Of Veterans Affairs Medical Center
state: Illinois
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre
state: British Columbia
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Pori
country: Finland
facility: Satasairaala Hospital
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital and Tampere University
city: Turku
country: Finland
facility: Turku University Hospital
city: Osaka
country: Japan
facility: Kindai University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Jussi Nikkola
role: PRINCIPAL_INVESTIGATOR
References: