NCT06026189

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
May 2023May 2027

Study Start

First participant enrolled

May 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

September 6, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

August 1, 2023

Last Update Submit

August 30, 2023

Conditions

HematuriaUrothelial NeoplasmUrothelial CarcinomaBladder Cancer

Keywords

Urinary biomarkerHematuriaUrothelial CarcinomaBladder Cancer

Outcome Measures

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.

    1 year

Secondary Outcomes (3)

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

    1 year

  • Cost-effectiveness analysis

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

  • Patient reported outcome measurements (PROMs)

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

Study Arms (2)

Care-as-usual

NO INTERVENTION

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

'Urine-first' strategy

EXPERIMENTAL

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.

Diagnostic Test: urine-first strategy

Interventions

urine-first strategyDIAGNOSTIC_TEST

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

'Urine-first' strategy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Microscopically confirmed microscopic hematuria of voided urine defined as ≥3 erythrocytes per high power field
  • Male patients ≥40 years
  • Female patients ≥50 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SeARCH-trial Pijpers

Rotterdam, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

HematuriaCarcinoma, Transitional CellUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteUrinary Bladder Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is a stepped wedge cluster randomized clinical trial
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: A multicenter, stepped wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 1, 2023

First Posted

September 6, 2023

Study Start

May 31, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

September 6, 2023

Record last verified: 2023-08

Locations

NL(1)