Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer

Urothelial Carcinoma Clinical Trial

— UROSCOUT-1  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310759
• Other study ID #: R21088B
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: March 2024
• Source: Tampere University Hospital
• Contact: Jussi Nikkola, MD PhD
• Phone: 03311611
• Email: jussi.nikkola[@]fimnet.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Locations

Country	Name	City	State
Canada	Vancouver Prostate Centre	Vancouver	British Columbia
Finland	Helsinki University Hospital	Helsinki
Finland	Tampere University Hospital and Tampere University	Tampere
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University

Countries where clinical trial is conducted

Canada,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Characteristics of urothelial cancers that were not detected by the utDNA test	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)	Immediately after pathological examination of surgical tissue
Other	Concordance between utDNA and urine cytology results	Concordance between utDNA and urine cytology results, with respect to positivity of the test	Immediately after completion of utDNA analysis and urine cytology
Primary	Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection	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	1 year after diagnostic workup
Secondary	Sensitivity and specificity of cystoscopy for urothelial cancer detection	Sensitivity and specificity of cystoscopy for urothelial cancer detection, using histologically confirmed cancer diagnoses within 1 year of the diagnostic workup as ground truth	1 year after diagnostic workup
Secondary	Sensitivity and specificity of urine cytology for urothelial cancer detection	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	1 year after diagnostic workup
Secondary	Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy	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
Secondary	Adverse event rate for cystoscopy	Adverse event rate for cystoscopy, based on CTCAE 5.0	4 weeks after cystoscopy
Secondary	Technical success rate of utDNA test	Fraction of all analyzed urine samples for which the analysis met the quality control criteria for a technically successful analysis	Immediately after utDNA sample analysis
Secondary	Estimate of diagnostic cystoscopies avoided	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)	4 weeks after cystoscopy
Secondary	Specificity of high-stringency utDNA threshold	Specificity of a high-stringency utDNA threshold (at least 2 known urothelial cancer driver mutations with allele fraction > 5%) for clinically detectable urothelial cancer	1 year after diagnostic workup