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

NCT04647981 | Completed

• 1 other identifier: 2018-A03392-53
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bladder; Cancer

Outcome Measures

Primary Outcomes (1)

• Compare sensitivities of the Xpert® Bladder Cancer Monitor Test and the urinary cytology test.

  The two tests, the Xpert® Bladder Cancer Monitor and the urinary cytology, made during the follow-up of patients with non-invasive-muscle bladder tumor are compared to the gold standard, which is the reference examination: the couple cystoscopy/histology.

  12 months

Secondary Outcomes (1)

• Evaluate the diagnostic accuracy of the Xpert® Bladder Cancer Monitor test.

  12 months

Study Arms (1)

Xpert® Bladder Test

A urine sample is collected before cystoscopy.

Other: Xpert® Bladder Cancer Monitor Test

Interventions

Xpert® Bladder Cancer Monitor Test OTHER

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

Xpert® Bladder Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A person with antecedents of non-invasive bladder tumors and who has had previous transurethral resection of bladder tumor.

You may qualify if:

• Participant has a social security scheme.
• Participant has signed a form of no objection to the use of the data.
• Participant is seen for a follow-up cystoscopy on the day of the visit.
• Vulnerable persons (Article L 1121-6 of the Public Health Code).
• Adults subject to legal protection or unable to express their consent (Article 1121-8 of the Public Health Code).
• Persons with a bladder tumor other than a non-invasive bladder tumor (i.e., invasive bladder cancer).

You may not qualify if:

• \- Participant no longer wishing to participate in the study, or in the course of the study with a refusal to use the data until exit from the study.

Sponsors & Collaborators

• Clinique Beau Soleil: lead
• Cepheid: collaborator
• Team Languedoc Mutualité / Nouvelles technologies: collaborator

Study Sites (1)

Clinique Beau Soleil

Montpellier, Hérault, 34070, France

Location

Related Links

• Qualitative monitoring for recurrence in patients previously diagnosed with bladder cancer in 90 minutes.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Mohamed Trabelssi, M.D.

  Clinique Beau Soleil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: May 22, 2019
• Primary Completion: December 15, 2020
• Study Completion: January 2, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)