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

NCT03715660 | Completed

• 1 other identifier: AE 2395
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Non muscle invasive bladder cancer, recurrence, progression

Outcome Measures

Primary Outcomes (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)

  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

Study Arms (1)

Xpert monitor- evaluated patients

EXPERIMENTAL

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

Interventions

Xpert bladder cancer monitor DIAGNOSTIC_TEST

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.

Xpert monitor- evaluated patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead
• Cepheid: collaborator

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Recurrence; Disease Progression

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 23, 2018
• Study Start: March 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

EG (1)