Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Diagnostic Test: Xpert bladder cancer monitor

• Registration Number: NCT03715660
• Lead Sponsor: Mansoura University

Brief Summary

The primary objective of this prospective, single-centre study is to establish the clinical performance characteristics of Xpert Bladder Cancer Monitor on the GeneXpert Instrument Systems in comparison to the methods currently used at the site for detecting recurrent bladder cancer.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-21
• Study First Posted: 2018-10-23
• Primary Completion: 2019-09-01
• Study Completion: 2019-10-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• The patient shall meet all of the following criteria in order to be considered eligible for enrollment:

  • Patient has been diagnosed with NMIBC within 24 months of enrollment
  • At the time of the enrollment visit, the patient is scheduled for a cystoscopy within the next 6 weeks of enrollment

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Exclusion Criteria

• Patient has had an excision procedure or BCG treatment within six weeks (42 days) before enrollment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Xpert monitor- evaluated patients	Xpert bladder cancer monitor	Xpert Bladder Cancer Monitor performance shall be established in recurrence patients relative to cystoscopy (for disease negative patients) or histology (for disease positive patients)and relative to a currently used diagnostic assay (urine cytology)which is the standard of care used for detecting recurrent bladder cancer at the site. In this study, clinical sensitivity shall be established in patients who have been previously diagnosed with bladder cancer and are scheduled for a standard of care (SOC) surveillance cystoscopy.

Primary Outcome Measures

Name	Time	Method
Accuracy of Xpert Bladder Cancer Monitor in monitoring of non muscle invasive bladder cancer by comparing its results to the results of the standard tool of monitoring of bladder cancer (diagnostic cystoscopy)	within 1 month after test assessment	Xpert Bladder Cancer Monitor performance shall be established in recurrence patients relative to cystoscopy (for disease negative patients) or histology (for disease positive patients)and relative to a currently used diagnostic assay (urine cytology)which is the standard of care used for detecting recurrent bladder cancer at the site. In this study, clinical sensitivity shall be established in patients who have been previously diagnosed with bladder cancer and are scheduled for a standard of care (SOC) surveillance cystoscopy

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansourah, Egypt