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

NCT ID: NCT06310759

Last Updated: 2025-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-08

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urothelial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jussi Nikkola

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Jesse Brown Department Of Veterans Affairs Medical Center

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Vancouver Prostate Centre

Vancouver, British Columbia, Canada

Site Status RECRUITING

Helsinki University Hospital

Helsinki, , Finland

Site Status RECRUITING

Satasairaala Hospital

Pori, , Finland

Site Status RECRUITING

Seinäjoki Central Hospital

Seinäjoki, , Finland

Site Status RECRUITING

Tampere University Hospital and Tampere University

Tampere, , Finland

Site Status RECRUITING

Turku University Hospital

Turku, , Finland

Site Status RECRUITING

Kindai University Hospital

Osaka, , Japan

Site Status RECRUITING

Countries

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United States Canada Finland Japan

Central Contacts

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Jussi Nikkola, MD PhD

Role: CONTACT

03311611 ext. +358

Facility Contacts

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Joel Cornfield

Role: primary

Peter Black

Role: primary

Tuomas Jalanko

Role: primary

Riikka Järvinen

Role: backup

Marjo Seppänen

Role: primary

Henry Haapiainen

Role: primary

Jussi Nikkola

Role: primary

Thea Veitonmäki

Role: backup

Pertti Nurminen

Role: primary

Peter Boström

Role: backup

Kazutoshi Fujita

Role: primary

Other Identifiers

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R21088B

Identifier Type: -

Identifier Source: org_study_id

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