TEST:

Bladder EpiCheck®

P2, N=262, Not yet recruiting, Chiti Arturo

BE addition to WLC, with PDD-guided biopsy performed for BE-positive cases, reveals the true performance of BE and WLC and significantly improves the detection of HG disease, allowing earlier intervention with potentially bladder-sparing options.

This review explores the current state of UTUC diagnosis, compares BE with conventional and emerging biomarkers, and discusses its clinical applications, limitations, and future perspectives. The integration of molecular biomarkers like BE into clinical practice has the potential to revolutionize UTUC diagnosis, improving patient outcomes through more precise, non-invasive detection strategies.

UroFollow is the first urine marker-based randomized trial in low/intermediate-risk NMIBC patients. We conclude that 6-monthly marker-based follow-up after negative 3-mo WLC is safe in this cohort. Results of contemporary urine markers suggest that their potential for use in marker-based surveillance, however, requires prospective confirmation.

Urinary biomarkers provide a promising noninvasive alternative for traditional BCa diagnostics with enhanced specificity and the possibility of early diagnosis. Future research should focus on large-scale clinical validation and standardization of biomarkers to facilitate their use in routine clinical practice.

"In 316 patients undergoing surveillance from July 2023 until August 2024, 38 cancers were detected, of which 29 were high-grade and 13 were carcinoma in situ (CIS), an aggressive form of bladder cancer often missed by white light cystoscopy, that can progress to muscle-invasive cancer if left untreated. White light cystoscopy detected 17 (59%) of the high-grade cases and 4 (31%) of the CIS cases versus 28 (97%) and 12 (92%), respectively, detected by Bladder EpiCheck and confirmed by photodynamic diagnosis (PDD) biopsies. Specificity was 97% (261/270) for cystoscopy and 94% (253/270) for Bladder EpiCheck. Additionally, Bladder EpiCheck was able to detect 65% more high-grade disease recurrences compared to white light cystoscopy (28 vs. 17), by performing biopsy under PDD in patients with a negative white light cystoscopy and a positive Bladder EpiCheck result. Nine of the 16 (56%) patients that were missed by white light cystoscopy but detected with Bladder EpiCheck and PDD had CIS."

P=N/A, N=100, Recruiting, Regina Elena Cancer Institute

The BE post-BCG status and variations in EpiScore values can help us identify patients at higher risk of any bladder cancer event and BCG failure promptly. These data can have an impact on disease management.

The consistently strong performance of BE indicate that a positive test could improve timely disease recurrence detection and a negative test could rule-out HG disease. Furthermore, the low rate of false positive results, potentially minimizes unnecessary downstream procedures and patient anxiety.

Bladder EpiCheck® is an effective diagnostic tool in UTUC, showing a promising diagnostic accuracy, with a Se and NPV of 85% and 84%, respectively. Its use in UTUC diagnosis and follow-up could reduce or postpone the need for more invasive procedures, such as URS, thereby reducing the procedure-associated risks and improving patients' quality of life. Although further research and large prospective studies are needed, the current results indicate that Bladder EpiCheck® is a promising tool in UTUC diagnosis, treatment decision-making, and follow-up.

P=N/A, N=600, Not yet recruiting, Nucleix Ltd.

BE may be useful in detecting residual tumor before second TUR and benefit in clinical decision making with high specificity and negative predictive value. These results encourage the use of BE to reduce number of unnecessary second TUR procedures. It may improve cost effectivity and quality of life as high numbered studies are needed to support these views and to incorporate BE into clinical practice.