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NCT Number: NCT06026189

Safely Reduce Cystoscopic Evaluations for Hematuria Patients

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.

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Key information

Conditions

Hematuria Bladder Cancer Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Bladder Diseases Urinary Bladder Neoplasms Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Urothelial Neoplasm

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SeARCH-trial Pijpers

Rotterdam, 3015GD, Netherlands

Location status: Recruiting

Location contact

J.L. Boormans, Prof. MD

CONTACT

[email protected]

0031 107040251

O.M. Pijpers, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urine-first strategy

Diagnostic Test

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

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. The number of cystoscopies and upper tract imaging modalities (CT or ultrasound) when using a 'urine-first' strategy versus 'care-as-usual'

    Time frame: 1 year

  2. Cost-effectiveness analysis

    Time frame: Questionnaires are administered at baseline, 3, 6, and 12 months.

    This will be performed according to the Dutch guideline by administering validated questionnaires.

  3. Patient reported outcome measurements (PROMs)

    Time frame: Questionnaires are administered at baseline, 3, 6, and 12 months.

    Patient-reported outcome measurements (PROMs) are assessed for patients undergoing cystoscopy and urine collection.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: SeARCH

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 6, 2023
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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