Safely Reduce Cystoscopic Evaluations for Hematuria Patients — SeARCH  

Bladder Cancer Clinical Trial

Official title: Safely Reduce Cystoscopic Evaluations for Hematuria Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Hematuria
• Urinary Bladder Neoplasms
• Urothelial Carcinoma
• Urothelial Neoplasm

• NCT number: NCT06026189
• Study type: Interventional
• Source: Erasmus Medical Center
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Completion date: May 31, 2027