Safely Reduce Cystoscopic Evaluations for Hematuria Patients (SeARCH)

Erasmus University

Status: Enrolling

Conditions: Bladder Cancer; Urothelial Neoplasm; Hematuria; Urothelial Carcinoma

Treatments: Diagnostic Test: urine-first strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06026189

Erasmus MC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 2 patient groups

Care-as-usual

No Intervention group

Description:

In the ''care-as-usual'' arm, all patients undergo 'care-as-usual', i.e. a cystoscopy and upper tract imaging (ultrasound or CT-scan)

'Urine-first' strategy

Experimental group

Description:

In the intervention arm, the urine test is used to triage patients for a diagnostic workup ('urine-first' strategy). Only patients with an abnormal test result undergo cystoscopy and upper tract imaging.

Treatment:

Diagnostic Test: urine-first strategy