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NCT04603612

The Role of mRNA-based Urine Test (Xpert Bladder Cancer Monitor) in Predicting the Need for Second Look Biopsy After Transurethral Resection of Non Muscle-invasive Bladder Tumor.

Completed NA Last updated 27 October 2020
What this trial tests

NA trial testing Primary TURBT in Bladder Cancer in 254 participants. Completed in 1 October 2020.

Timeline
1 June 2018
Primary endpoint
1 September 2020
1 October 2020

Quick facts

Lead sponsorMansoura University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment254
Start date1 June 2018
Primary completion1 September 2020
Estimated completion1 October 2020
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Mansoura University

Who can join

18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Xpert BC Monitor is an mRNA-based urinary marker test for BC surveillance which measures the levels of five target mRNAs (ABL1, ANXA10, UPK1B, CRH and IGF2) from a voided urine sample by real-time RT-PCR. The Xpert BC Monitor automates and integrates sample processing, nucleic acid amplification, and the detection of target sequences. The performance of Xpert BC monitor regarding its sensitivity and negative predictive value was shown to be considerably high reaching 84% and 93%, respectively. Moreover, this high sensitivity was maintained in low-grade (77%) and Ta tumors (82%). Xpert BC monitor is going to gain now a wide popularity among practitioners in surveillance of NMIBC patients due to its simplicity to do, reliability and reproducibility. The investigators hypothesize that; Xpert BC monitor may be a useful tool in evaluation of patients, who are potentially candidates for repeat TURBT. It can refine the indications of repeat biopsy by exclusion of cases with negative test.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Bladder Cancer

Currently open trials in the same condition.

Other Mansoura University trials

Trials by the same sponsor.

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Data sources for this page

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