Safely Reduce Cystoscopic Evaluations for Hematuria Patients

Not Applicable

Recruiting

• Conditions: Hematuria; Urothelial Neoplasm; Urothelial Carcinoma; Bladder Cancer
• Interventions: Diagnostic Test: urine-first strategy

• Registration Number: NCT06026189
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2023-05-31
• Status Verified: 2023-08
• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-30
• Last Update Submitted: 2023-08-30
• Study First Posted: 2023-09-06
• Last Update Posted: 2023-09-06
• Primary Completion: 2026-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
'Urine-first' strategy	urine-first strategy	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.

Primary Outcome Measures

Name	Time	Method
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.	1 year	The net benefit is defined as the proportion of patients who were diagnose with urinary tract cancer within 1 year after initial diagnostic work-up in the population (true positives) subtracted by the proportion of patients that underwent diagnostic evaluations without an abnormal finding (false positives). The latter is multiplied by the decision threshold, which represents the estimated harms of the diagnostic intervention, such as patients' burden and use of available resources, against the harms of an outcome event, i.e. missing a urinary tract tumor.

Secondary Outcome Measures

Name	Time	Method
The number of cystoscopies and upper tract imaging modalities (CT or ultrasound) when using a 'urine-first' strategy versus 'care-as-usual'	1 year
Cost-effectiveness analysis	Questionnaires are administered at baseline, 3, 6, and 12 months.	This will be performed according to the Dutch guideline by administering validated questionnaires.
Patient reported outcome measurements (PROMs)	Questionnaires are administered at baseline, 3, 6, and 12 months.	Patient-reported outcome measurements (PROMs) are assessed for patients undergoing cystoscopy and urine collection.

Trial Locations

Locations (1)

SeARCH-trial Pijpers; 🇳🇱 Rotterdam, Netherlands