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

NCT06310759 | Recruiting

• 1 other identifier: R21088B
• Study Type: observational
• Target: 3,000
• Locations: 4 countries
• Sites: 8

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.

Conditions

Urothelial Carcinoma

Keywords

Urothelial neoplasms; Bladder neoplasms; Upper tract urothelial neoplasms; Liquid biopsies; Urine tumor DNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Sensitivity and specificity of cystoscopy for urothelial cancer detection

  1 year after diagnostic workup

• Sensitivity and specificity of urine cytology for urothelial cancer detection

  1 year after diagnostic workup

• 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

• Adverse event rate for cystoscopy

  4 weeks after cystoscopy

• Technical success rate of utDNA test

  Immediately after utDNA sample analysis

Other Outcomes (2)

• Characteristics of urothelial cancers that were not detected by the utDNA test

  Immediately after pathological examination of surgical tissue

• Concordance between utDNA and urine cytology results

  Immediately after completion of utDNA analysis and urine cytology

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for diagnostic cystoscopy to rule out urothelial cancer due to hematuria, imaging, or urine cytology findings.

You may qualify if:

• Willing and able to provide informed consent
• Patient has been scheduled for cystoscopy to rule out urothelial cancer

You may not qualify if:

• Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator

Study Sites (8)

Jesse Brown Department Of Veterans Affairs Medical Center

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

Vancouver Prostate Centre

Vancouver, British Columbia, Canada

RECRUITING

Helsinki University Hospital

Helsinki, Finland

RECRUITING

Satasairaala Hospital

Pori, Finland

RECRUITING

Seinäjoki Central Hospital

Seinäjoki, Finland

RECRUITING

Tampere University Hospital and Tampere University

Tampere, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

Kindai University Hospital

Osaka, Japan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jussi Nikkola

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jussi Nikkola, MD PhD

CONTACT

03311611; jussi.nikkola@fimnet.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 15, 2024
• Study Start: January 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

JP (1); CA (1); FI (5); US (1)