Safely Reduce Cystoscopic Evaluations for Hematuria Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorErasmus Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Microscopically confirmed microscopic hematuria of voided urine defined as ≥3 erythrocytes per high power field
Male patients ≥40 years
Female patients ≥50 years
Disqualifiers
History of urothelial bladder- or urinary tract cancer
Presence of macroscopic (visible) hematuria
Woman who is or may be pregnant
Trial design
Design model
Parallel
Treatments tested in this trial
urine-first strategy
Diagnostic testOnly patients with an abnormal urine test result undergo a diagnostic workup, i.e. cystoscopy and upper-tract imaging.
Treatment groups
1,100 Participants
are divided into 2 treatment groupsGroup A: Care-as-usualNo intervention 0 interventions
Group B: 'Urine-first' strategyExperimental treatment 1 intervention
Trial outcomes
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.
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.
Time frame
1 yearSecondary 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 year2
Cost-effectiveness analysis
This will be performed according to the Dutch guideline by administering validated questionnaires.
Time frame
Questionnaires are administered at baseline, 3, 6, and 12 months.3
Patient reported outcome measurements (PROMs)
Patient-reported outcome measurements (PROMs) are assessed for patients undergoing cystoscopy and urine collection.
Time frame
Questionnaires are administered at baseline, 3, 6, and 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov