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

Официальное название

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)

Обзор

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.

Первичные конечные точки

• Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection [Срок оценки: 1 year after diagnostic workup]

Вторичные конечные точки (7)

• Sensitivity and specificity of cystoscopy for urothelial cancer detection [Срок оценки: 1 year after diagnostic workup]
• Sensitivity and specificity of urine cytology for urothelial cancer detection [Срок оценки: 1 year after diagnostic workup]
• Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy [Срок оценки: 2, 5, and 10 years after diagnostic utDNA testing]
• Adverse event rate for cystoscopy [Срок оценки: 4 weeks after cystoscopy]
• Technical success rate of utDNA test [Срок оценки: Immediately after utDNA sample analysis]
• Estimate of diagnostic cystoscopies avoided [Срок оценки: 4 weeks after cystoscopy]
• Specificity of high-stringency utDNA threshold [Срок оценки: 1 year after diagnostic workup]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Финляндия · 5 центров

• Helsinki University Hospital — Helsinki
• Satasairaala Hospital — Pori
• Seinäjoki Central Hospital — Seinäjoki
• Tampere University Hospital and Tampere University — Tampere
• Turku University Hospital — Turku

США · 1 центр

• Jesse Brown Department Of Veterans Affairs Medical Center — Chicago

Канада · 1 центр

• Vancouver Prostate Centre — Vancouver

Япония · 1 центр

• Kindai University Hospital — Osaka

Идентификаторы

NCT: NCT06310759 · R21088B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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