TEST:

Uromonitor®

The MODAPLEX FGFR panel allows the stratification of bladder cancer patients by determination of the FGFR3 mutational and FGFR2/3 fusion status. The PCR-based FGFR assessment by MODAPLEX FGFR panel and therascreen FGFR kit is highly concordant (78/79). The MODAPLEX assays enable fast, local FGFR assessment in a multiplexed one-step approach within few hours.

Despite its innovative approach, Uromonitor fell short of confirming the superior results anticipated from previous studies in this real-world setting. The search for an optimal urine-based biomarker for detecting and monitoring UCB remains ongoing. Results from this study highlight the complexity of developing non-invasive diagnostic tools and emphasise the importance of continued research efforts to refine these technologies.

P=N/A; Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> May 2024

In the present trial, we confirmed that the Uromonitor® biomarker test represents a reliable tool in the detection of NMIBC recurrence in patients undergoing routine surveillance, regardless of stage and grade. It offers either an alternative or a complement to the current SOC methods, providing rapid results and a non-invasive option, potentially improving patients' quality of life and helping reduce the economic burden of NMIBC follow-up. To our knowledge, this is the largest single-center study assessing Uromonitor®´s performance and thus validating its usefulness in clinical practice.

The determination of Mxi-2 and Vim3 in urine enables rapid and cost-effective differentiation between NMIBC and MIBC with a high diagnostic accuracy for tailored surgical and therapeutic evaluation. Prospective validation of urine-based prediction of muscle invasiveness is ongoing in the prospective, multicenter Bladder BRIDGister study. In addition, biomarker results are being compared with multiparametric MRI to provide an integrated, non-invasive platform for robust MIBC classification prior to surgery.

In a cohort of 1000 patients with a bladder-cancer prevalence of ~15%, this UBDT would avert 825 unnecessary cystoscopies (true-negatives) while missing 30 bladder-cancer cases (false-negatives). Due to currently limited aggregated data from only four studies with heterogeneous quality, confirmatory studies are needed.

No abstracts available

No abstracts available

P=N/A; N=600; Active, not recruiting; Sponsor:Pharmalink

Background: In view of the efficacy of FGFR targeting in early and advanced bladder cancer, as has been shown for erdafitinib in the THOR and NORSE trial, molecular testing of FGFR mutations and fusions will soon become clinical routine worldwide... PCR-based FGFR assessment by Therascreen and UroTyper is highly concordant and enables fast, local FGFR assessment within few hours. FGFR3 mutations are associated with increased TROP2 & NECTIN4 expression indicating potential synergistic options which warrants further exploration as part of molecularly stratified clinical trials.

P=N/A, N=16, Recruiting, VA Office of Research and Development | Trial primary completion date: Mar 2024 --> Oct 2024

P=N/A; Recruiting --> Active, not recruiting

It provides either an alternative or a compliment to the current SOC methods as it provides rapid results and a non-invasive option, potentially improving patients’ quality of life and helping reduce the economic burden of NMIBC follow-up. To our knowledge this is the largest single center study assessing Uromonitor-V2®´s performance, and thus validating its usefulness in clinical practice.

Wireless, catheter-free devices may offer an alternative to traditional bladder assessment techniques permitting more natural, comfortable observation of lower urinary tract dysfunction after neurological injury in pre-clinical animals and humans. The present study tested two devices that can reliably identify and quantify bladder contractions before and after SCI in a large animal model with a high degree of accuracy.

P=N/A; Not yet recruiting --> Recruiting

P=N/A; N=600; Not yet recruiting; Sponsor:Pharmalink

Uromonitor displays high diagnostic accuracy in detecting NMIBC recurrence with the potential for reducing the number of flexible cystoscopies in the follow-up of low- and intermediate-risk NMIBC.

No abstracts available

P=N/A; N=343; Not yet recruiting; Sponsor:Clinica Universidad de Navarra, Universidad de Navarra

Filtering urine for cells and subsequent DNA extraction followed by PCR detection results in highly sensitive mutation testing being feasible with good concordance to matched tissue testing. Prospective testing validated the diagnostic accuracy of the Uromonitor FGFR test in a real world setting.

No abstracts available

There is not enough data to reliably assess their use in the primary diagnostic setting. These results have to be confirmed in larger cohort as well as in head-to-head comparative studies.

"Our analyses support high diagnostic accuracy of the studied novel UBTs, supporting their utility in the NMIBC surveillance setting. All of these might potentially help prevent unnecessary cystoscopies safely. There are not enough data to reliably assess their use in the primary diagnostic setting. These results have to be confirmed in a larger cohort as well as in head-to-head comparative studies. Nevertheless, our study might help policymakers and stakeholders evaluate the clinical and social impact of the implementation of these tests into daily practice."