Bladder Cancer
Conditions
Keywords
Non muscle invasive bladder cancer, recurrence, progression
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.
Interventions
DIAGNOSTIC_TESTXpert 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.
Sponsors
Cepheid
Mansoura University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed