Safely Reduce Cystoscopic Evaluations for Hematuria Patients

NCT06026189 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Erasmus Medical Center

Phase

Not applicable

Started

2023-05-31

Last updated

2023-09-06

Condition(s) studied

HematuriaUrothelial NeoplasmUrothelial CarcinomaBladder Cancer

Investigational drug(s) / intervention(s)

urine-first strategy

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

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

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 Exclusion Criteria: * History of urothelial bladder- or urinary tract cancer * Presence of macroscopic (visible) hematuria * Woman who is or may be pregnant

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
SeARCH-trial Pijpers	Rotterdam	Netherlands	Recruiting

More Erasmus Medical Center trials in the Netherlands

Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors Recruiting

Surveillance of Respiratory Viruses in Healthcare and Animal Workers Recruiting

Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics Recruiting

FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test Recruiting

GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients Recruiting

Other trials for the same condition

KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04) Recruiting

Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Active, not recruiting

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003) Recruiting

Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer Recruiting

Study With a Newly Optical Coherence Tomography Probe for Optimizing Bladder Cancer Diagnosis and Treatment Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06026189 on ClinicalTrials.gov ↗ ← All trials in the Netherlands