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Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test.

NCT04647981 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2021-02-09

No results posted yet for this study

Summary

Non-muscle invasive bladder tumor is a condition that can recur with a risk of progression to an infiltrating tumor of the muscle. Regular follow-up is therefore essential to detect any recurrence or progression of the disease as early as possible.

Currently, the monitoring of this type of tumor is done by cystoscopy (examination that allows visualization of the bladder wall) associated with urinary cytology (analysis of urine to detect an abnormality). These examinations have their limits, they may not detect certain types of tumors or may be painful.

To reduce the number of cystoscopies and replace urinary cytology, several urinary markers have been developed in recent years. This is the case of the Xpert® Bladder Cancer Monitor test, which is a non-invasive, in vitro diagnostic urine test dedicated to the monitoring of patients with bladder cancer.

The purpose of this study is to evaluate the diagnostic performance of the Xpert® Bladder Cancer Monitor test for the detection of bladder tumor recurrence, compared to reference tests.

Conditions

  • Non-Invasive Bladder Urothelial Carcinoma
  • Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade
  • Non-Invasive Bladder Papillary Urothelial Carcinoma, High Grade

Interventions

OTHER

Xpert® Bladder Cancer Monitor Test

The urine sample is analyzed with the Xpert® Bladder Cancer Monitor test.

Sponsors & Collaborators

  • Cepheid

    collaborator INDUSTRY

  • Team Languedoc Mutualité / Nouvelles technologies

    collaborator UNKNOWN

  • Clinique Beau Soleil

    lead OTHER

Principal Investigators

  • Mohamed Trabelssi, M.D. · Clinique Beau Soleil

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2020-12-15
Completion
2021-01-02

Countries

  • France

Study Locations

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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 NCT04647981 on ClinicalTrials.gov