Reducing invasive tests for patients with blood in urine
Safely Reduce Cystoscopic Evaluations for Hematuria Patients
This study is testing a new urine test to see if it can help people with blood in their urine avoid unnecessary invasive procedures while still checking for serious conditions like bladder cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT06026189 on ClinicalTrials.gov |
What this trial studies
The SeARCH-trial evaluates the effectiveness of a molecular urine test as a primary diagnostic tool for patients with microscopic hematuria, which can indicate serious conditions like bladder cancer. Currently, most patients undergo invasive procedures such as cystoscopy, despite a low cancer risk of 2-5%. This trial aims to implement a 'urine-first' strategy, where only those with abnormal urine test results will proceed to invasive diagnostics. The study will also assess patient preferences, reported outcomes, and healthcare costs to determine the overall impact on patient quality of life.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 40 and older or female patients aged 50 and older with confirmed microscopic hematuria.
Not a fit: Patients with a history of urothelial bladder or urinary tract cancer or those presenting with visible hematuria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce unnecessary invasive procedures and improve patient comfort and resource allocation.
How similar studies have performed: Previous studies have shown promising results with similar urine assays, indicating potential for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rotterdam
- SeARCH-trial Pijpers — Rotterdam, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.