Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study
NCT ID: NCT03715660
Last Updated: 2019-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
198 participants
INTERVENTIONAL
2018-03-01
2019-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Xpert monitor- evaluated patients
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Cepheid
INDUSTRY
Mansoura University
OTHER
Responsible Party
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Amr Abdel-Lateif El-Sawy
Principal Investigator
Locations
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Urology and Nephrology Center
Al Mansurah, , Egypt
Countries
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Other Identifiers
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AE 2395
Identifier Type: -
Identifier Source: org_study_id
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