TEST:

Xpert® Bladder Cancer Monitor

P=N/A; Overall trial duration is estimated at 5 yr from when the study opens to enrollment until completion of data analyses. The trial is registered at clinicaltrials.gov (NCT05796375).

P=N/A; N=150; Enrolling by invitation; Sponsor:Jørgen Bjerggaard Jensen

"Based on the results of this simulation, a marker-supported follow-up of patients with HR NMIBC is safe and offers the option to significantly reduce the number of WLCs. Further research focusing on prospective randomized trials is needed to finally find a way to implement urine markers into clinical decision-making."

No abstracts available

P=N/A; Not yet recruiting --> Recruiting | Initiation date: Aug 2023 --> Nov 2023

Xpert monitor was not superior than clinical assessment in predicting the need for 2nd TURB. It might be an option to omit 2nd TURB for selected patients with pTa disease.

After searching for the best XBM cutoff for detecting the 38 high-risk initial recurrences and the early high-risk recurrences after a one-year follow-up, a linear discriminant analysis (LDA) of 0.13 could have avoided 11.3% of cystoscopies and bladder wash cytologies, as this cutoff missed only 1 high-risk recurrence (2.6%). More extensive and well-designed studies will confirm if XBM can improve the surveillance of NMIBC.

P=N/A; Phase classification: P3 --> P=N/A

P=N/A | N=240 | Not yet recruiting | Sponsor: White River Junction Veterans Affairs Medical Center

The findings of the present study support the hypothesis that replacing cystoscopy with XBCM can reduce the use of antibiotics for UTI during follow-up of NMIBC. Thus, the morbidity of follow-up of NMIBC with FC can be reduced, resulting perhaps in less development of multiresistant uropathogenic bacteria and increased quality of life.

"Bladder-Epicheck® and Urovysion®FISH along with cytology could be a helpful ancillary method in the diagnosis and follow-up of UTUC while due to its low specificity Xpert®-BC Detection seems to be of limited usefulness."

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

"Urinary biomarkers might have a complementary place in bladder cancer diagnosis and NMIBC surveillance. However, their clinical benefit remains to be confirmed."

With this comment, author highlighted the strengths and limitations of the study. With this response, we respond to this and make a comparison of the results and conclusions.

The SP of FISH was significantly higher. By using FISH and Xpert in addition to cystoscopy, renal and bladder US, and/or CTU in the diagnostic workup of patients with hematuria and follow-up after transurethral resection of the bladder (TURB), a substantial number of patients (10%) otherwise missed were discovered to have UC.

P3; Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Apr 2027 | Trial primary completion date: Oct 2023 --> Apr 2024

NPV was 81.4% for cytology, 100% for Xpert® BC-Detection, and 96.2% for Urovysion. The excellent NPV of Xpert® BC-Detection allows to avoid unnecessary endoscopic exploration of the UT, reducing invasiveness and URS complications in the follow-up of UTUC.

P3; Trial completion date: Sep 2029 --> Sep 2024 | Trial primary completion date: Oct 2022 --> Oct 2023

NBI cystoscopy does not necessarily provide additional benefit over standard WLC. However, the XBCM may provide better SE and a diagnostic advantage in instances of HG disease recurrence.

and 84.1, respectively. Our findings suggest that Xpert BC Monitor assay, when it is longitudinally repeated, could significantly reduce the number of unnecessary cystoscopies and UC during their follow-up.

No abstracts available

No abstract 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.

Xpert BC monitor has overall acceptable diagnostic accuracy. Sensitivity is higher for high-grade disease for detecting recurrences in patients with NMIBC on surveillance.

With this study, authors evaluated diagnostic accuracy of Xpert bladder cancer monitor in detecting recurrences. With this article, we highlight the strengths and limitations of the study.

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

NBI cystoscopy does not necessarily offer any additional benefit to standard WLC, and WLC remains the gold standard for visualization in NMIBC surveillance. Yet, the XPER

No abstracts available

"The Xpert test has a high sensitivity for detecting the recurrence of cancer and a high negative predictive value for excluding HG cancer. In addition, the data suggest that patients with a positive Xpert assay in setting of negative cystoscopy are at high risk for recurrence and need close surveillance."

Xpert BC Monitor performance was superior to that of cytology in the follow-up of NMIBC. The exclusion of aggressive tumours with a very high NPV (99.7%) supports the use of this urinary test in daily practice.

The XBC showed significantly higher overall sensitivity and negative predictive value than VUC and could be used to increase the recommended follow-up cystoscopy time intervals. Complementing the XBC and voided urinary cytology does not improve performance in comparison to the XBC alone.

The test performed very well in terms of specificity but could not reach the high value of cytology. Along with voided urinary cytology the test could allow to reduce cystoscopies in follow-up patients, reducing discomfort to the patients and costs.

No abstract available

No abstract available