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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715660
• Other study ID #: AE 2395
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: November 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: October 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• Xpert bladder cancer monitor
Xpert Bladder Cancer Monitor, is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with bladder cancer.The test utilizes a voided urine specimen and measures the levels of five targetmRNAs (ABL1, CRH, IGF2, UPK1B, ANXA10) by means of real-time, reverse transcription-polymerase chain reaction (RT-PCR). The Xpert Bladder Cancer Monitor is indicated as an aid to standard clinical evaluation in monitoring for bladder cancer recurrence in patients previously diagnosed with bladder cancer and should be used in conjunction with other clinical measures to assess disease recurrence.

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansourah

Sponsors (2)

Lead Sponsor	Collaborator
Mansoura University	Cepheid

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	within 1 month after test assessment