SeARCH-trial

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:

• uncomfortable and stressful; up to 30% of the patients are anxious and 25% had an elevated depression score due to the cystoscopy.
• Has a significant impact on limited available resources; the estimated direct medical costs are €115.06 and €239.62 per patient, respectively.
• 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.

Read more about the urine based molecular assay:

• de Jong JJ,  et al. A Urine-based Genomic Assay Improves Risk Stratification for Patients with High-risk Hematuria Stratified According to the American Urological Association Guidelines. Eur Urol Oncol. 2023 https://pubmed.ncbi.nlm.nih.gov/36089502/
• van Kessel KEM, et al. A Urine Based Genomic Assay to Triage Patients with Hematuria for Cystoscopy. J Urol. 2020 https://pubmed.ncbi.nlm.nih.gov/31985322/