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Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor

NCT04100733 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2023-06-01

No results posted yet for this study

Summary

The study aims to evaluate the potential clinical impact of a highly sensitive urinary marker, the Xpert Bladder Cancer Monitor, regarding possible reduction in number of flexible cystoscopies in an outpatient setting without decreasing recurrence-free survival or increasing risk of progression.

Conditions

Interventions

DIAGNOSTIC_TEST

Xpert Bladder Cancer Monitor

Xpert Bladder Cancer Monitor detects mRNA fragments from 5 genes frequently overexpressed in non-muscle invasive bladder cancer.

DIAGNOSTIC_TEST

Flexible cystoscopy (WL/NBI) and urinary cytology

Adhering to current danish guidelines for follow-up of non-muscle invasive bladder cancer.

Sponsors & Collaborators

  • Cepheid

    collaborator INDUSTRY

  • Jørgen Bjerggaard Jensen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2024-04-30
Completion
2027-04-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04100733 on ClinicalTrials.gov