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

Mansoura University

Status: Completed

Conditions: Bladder Cancer

Treatments: Diagnostic Test: Xpert bladder cancer monitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03715660

AE 2395

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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198 participants in 1 patient group

Xpert monitor- evaluated patients

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Xpert bladder cancer monitor