Идёт набор NCT06026189

Safely Reduce Cystoscopic Evaluations for Hematuria Patients

Без фазы С лечением Hematuria Urothelial Neoplasm Urothelial Carcinoma Bladder Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: urine-first strategy.
Кому может быть актуально: Состояния в реестре: Hematuria, Urothelial Neoplasm, Urothelial Carcinoma, Bladder Cancer. Базовые параметры: Без ограничений · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The SeARCH-trial assess the clinical impact of a molecular urine test as a 'urine-first' strategy in the diagnostic workup of patients presenting with microscopic hematuria.

Подробное описание

Microscopic hematuria (MH) can be a sign of an underlying disease, including malignancy of the urinary tract, and is reason for referral to a urology clinic. The current standard diagnostic workup for MH patients includes visual inspection of the bladder by cystoscopy and upper tract imaging to rule out the presence of a tumor in the urinary tract. However, the a priori risk of cancer in patients with MH is only 2-5%. Consequently, 95% of MH patients unnecessarily undergo invasive procedures, which are: I) uncomfortable and stressful for patients, II) has a significant impact on limited available (financial) resources and III) a CT scan is accompanied by exposure to ionizing radiation.

Previously we developed a molecular urine assay to detect urinary tract cancer in hematuria patients that had robust diagnostic performance; a negative predictive value \>99%, sensitivity, and specificity \>90%. The SeARCH-trial evaluates the clinical impact of a urine assay as a 'urine-first' strategy, meaning that only patients with an abnormal urine test results undergo invasive diagnostics. In this multicenter stepped-wedge cluster randomized trial we compare clinical outcomes by using a 'urine-first' strategy to 'care-as-usual', which is a cystoscopy and upper tract imaging in all patients presenting with MH. In addition, we assess patients' preferences, patients reported outcome measurements, and healthcare costs to show that a 'urine-first' strategy improves patients' quality of life and results in a more appropriate use of limited available resources.

Вмешательства

Диагностический тест urine-first strategy
Only patients with an abnormal urine test result undergo a diagnostic workup, i.e. cystoscopy and upper-tract imaging.

Первичные конечные точки

The primary aim of the SeARCH-trial is to assess the clinical impact of implementing a molecular urinary assay as a 'urine-first' strategy, in the diagnostic workup of patients presenting with microscopic hematuria. [Срок оценки: 1 year]

Вторичные конечные точки (3)

The number of cystoscopies and upper tract imaging modalities (CT or ultrasound) when using a 'urine-first' strategy versus 'care-as-usual' [Срок оценки: 1 year]
Cost-effectiveness analysis [Срок оценки: Questionnaires are administered at baseline, 3, 6, and 12 months.]
Patient reported outcome measurements (PROMs) [Срок оценки: Questionnaires are administered at baseline, 3, 6, and 12 months.]

Критерии участия

Критерии включения

Microscopically confirmed microscopic hematuria of voided urine defined as ≥3 erythrocytes per high power field
Male patients ≥40 years
Female patients ≥50 years