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Safely Reduce Cystoscopic Evaluations for Hematuria Patients (SeARCH)

Primary Purpose

Hematuria, Urothelial Neoplasm, Urothelial Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
urine-first strategy
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hematuria focused on measuring Urinary biomarker, Hematuria, Urothelial Carcinoma, Bladder Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • SeARCH-trial PijpersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Care-as-usual

'Urine-first' strategy

Arm Description

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

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.

Outcomes

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.
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'
Cost-effectiveness analysis
This will be performed according to the Dutch guideline by administering validated questionnaires.
Patient reported outcome measurements (PROMs)
Patient-reported outcome measurements (PROMs) are assessed for patients undergoing cystoscopy and urine collection.

Full Information

First Posted
August 1, 2023
Last Updated
August 30, 2023
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06026189
Brief Title
Safely Reduce Cystoscopic Evaluations for Hematuria Patients
Acronym
SeARCH
Official Title
Safely Reduce Cystoscopic Evaluations for Hematuria Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematuria, Urothelial Neoplasm, Urothelial Carcinoma, Bladder Cancer
Keywords
Urinary biomarker, Hematuria, Urothelial Carcinoma, Bladder Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A multicenter, stepped wedge cluster randomized trial
Masking
None (Open Label)
Masking Description
This is a stepped wedge cluster randomized clinical trial
Allocation
Randomized
Enrollment
1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care-as-usual
Arm Type
No Intervention
Arm Description
In the ''care-as-usual'' arm, all patients undergo 'care-as-usual', i.e. a cystoscopy and upper tract imaging (ultrasound or CT-scan)
Arm Title
'Urine-first' strategy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
urine-first strategy
Intervention Description
Only patients with an abnormal urine test result undergo a diagnostic workup, i.e. cystoscopy and upper-tract imaging.
Primary Outcome Measure Information:
Title
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.
Description
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 year
Secondary Outcome Measure Information:
Title
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
Title
Cost-effectiveness analysis
Description
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.
Title
Patient reported outcome measurements (PROMs)
Description
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
SeARCH-trial Pijpers
City
Rotterdam
ZIP/Postal Code
3015GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.L. Boormans, Prof. MD
Phone
0031 107040251
Email
search.studie@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
O.M. Pijpers, MD

12. IPD Sharing Statement

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Safely Reduce Cystoscopic Evaluations for Hematuria Patients

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