SeARCH: Safely Reduce Cystoscopic Evaluations for Hematuria Patients

Sponsor

Erasmus Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06026189

Collaborator

(none)

1,100

Enrollment

Location

Arms

Anticipated Duration (Months)

22.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematuria Urothelial Neoplasm Urothelial Carcinoma Bladder Cancer	Diagnostic Test: urine-first strategy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A multicenter, stepped wedge cluster randomized trialA multicenter, stepped wedge cluster randomized trial

Masking:

None (Open Label)

Masking Description:

This is a stepped wedge cluster randomized clinical trial

Primary Purpose:

Diagnostic

Official Title:

Safely Reduce Cystoscopic Evaluations for Hematuria Patients

Actual Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

May 31, 2026

Anticipated Study Completion Date :

May 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Care-as-usual In the ''care-as-usual'' arm, all patients undergo 'care-as-usual', i.e. a cystoscopy and upper tract imaging (ultrasound or CT-scan)
Experimental: '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.	Diagnostic Test: urine-first strategy Only patients with an abnormal urine test result undergo a diagnostic workup, i.e. cystoscopy and upper-tract imaging.

Arm

Intervention/Treatment

No Intervention: Care-as-usual

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

Experimental: '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.

Diagnostic Test: urine-first strategy

Only patients with an abnormal urine test result undergo a diagnostic workup, i.e. cystoscopy and upper-tract imaging.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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