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

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03715660
• Collaborator: Cepheid (Industry)
• Enrollment: 198
• Location: 1
• Arm: 1
• Actual Duration (Months): 19
• Patients Per Site Per Month: 10.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Diagnostic Test: Xpert bladder cancer monitor	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 198 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology and Nephrology Center	Mansourah		Egypt	35516

Sponsors and Collaborators

• Mansoura University
• Cepheid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amr Abdel-Lateif El-Sawy, Principal Investigator, Mansoura University
• ClinicalTrials.gov Identifier: NCT03715660
• Other Study ID Numbers: AE 2395
• First Posted: Oct 23, 2018
• Last Update Posted: Nov 21, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Amr Abdel-Lateif El-Sawy, Principal Investigator, Mansoura University: Non muscle invasive bladder cancer, recurrence, progression
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Nov 21, 2019