Clinical trial NCT06026189: Safely Reduce Cystoscopic Evaluations for Hematuria Patients
Official title: Safely Reduce Cystoscopic Evaluations for Hematuria Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematuria
Urothelial Neoplasm
Urothelial Carcinoma
Bladder Cancer
Keywords: Urinary biomarker
Hematuria
Urothelial Carcinoma
Bladder Cancer
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 1100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, stepped wedge cluster randomized trial
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* History of urothelial bladder- or urinary tract cancer
* Presence of macroscopic (visible) hematuria
* Woman who is or may be pregnant

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: The number of cystoscopies and upper tract imaging modalities (CT or ultrasound) when using a 'urine-first' strategy versus 'care-as-usual'
timeFrame: 1 year
measure: Cost-effectiveness analysis
timeFrame: Questionnaires are administered at baseline, 3, 6, and 12 months.
measure: Patient reported outcome measurements (PROMs)
timeFrame: Questionnaires are administered at baseline, 3, 6, and 12 months.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: SeARCH-trial Pijpers
Study officials:
References: