Diagnostic performance of the Bladder EpiCheck methylation test and photodynamic diagnosis-guided cystoscopy in the surveillance of high-risk non-muscle invasive bladder cancer: A single centre, prospective, blinded clinical trial

Cochetti, Giovanni; Vermandois, J.A. Rossi De; Maulà, Vincenza; Cari, Luigi; Cagnani, Rosy; Suvieri, Chiara; Balducci, Pierfrancesco Maria; Paladini, Alessio; Zingaro, Michele Del; Nocentini, Giuseppe; Mearini, Ettore

doi:10.1016/j.urolonc.2021.11.001

Cited by 22 publications

(16 citation statements)

References 22 publications

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“…In general, the NPV was 96.77% for both the cytology and DNA methylation test in highgrade lesions, but when we analyzed all the lesions, the methylation test showed an value of the NPV, arising to 97.14% and cytology arising to 94.12%. These findings confirm the NPV of the DNA methylation test [34,35]. In addition, molecular markers can help improve the interpretation capacity of other diagnostic tests, such as urine cytology, through positive feedback.…”

Section: Discussionsupporting

confidence: 69%

Usefulness of the Urine Methylation Test (Bladder EpiCheck®) in Follow-Up Patients with Non-Muscle Invasive Bladder Cancer and Cytological Diagnosis of Atypical Urothelial Cells—An Institutional Study

Peña

Riu

Hernández-Aguilera

et al. 2022

JCM

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Urothelial bladder cancer is a heterogeneous disease and one of the most common cancers worldwide. Bladder cancer ranges from low-grade tumors that recur and require long-term invasive surveillance to high-grade tumors with high mortality. After the initial contemporary treatment in non-muscle invasive bladder cancer, recurrence and progression rates remain high. Follow-up of these patients involves the use of cystoscopies, cytology, and imaging of the upper urinary tract in selected patients. However, in this context, both cystoscopy and cytology have limitations. In the follow-up of bladder cancer, the finding of urothelial cells with abnormal cytological characteristics is common. The main objective of our study was to evaluate the usefulness of a urine DNA methylation test in patients with urothelial bladder cancer under follow-up and a cytological finding of urothelial cell atypia. In addition, we analyzed the relationship between the urine DNA methylation test, urine cytology, and subsequent cystoscopy study. It was a prospective and descriptive cohort study conducted on patients presenting with non-muscle invasive urothelial carcinoma between 1 January 2018 and 31 May 2022. A voided urine sample and a DNA methylation test was extracted from each patient. A total of 70 patients, 58 male and 12 female, with a median age of 70.03 years were studied. High-grade urothelial carcinoma was the main histopathological diagnosis. Of the cytologies, 41.46% were cataloged as atypical urothelial cells. The DNA methylation test was positive in 17 urine samples, 51 were negative and 2 were invalid. We demonstrated the usefulness of a DNA methylation test in the follow-up of patients diagnosed with urothelial carcinoma. The methylation test also helps to diagnose urothelial cell atypia.

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Section: Discussionsupporting

confidence: 69%

Usefulness of the Urine Methylation Test (Bladder EpiCheck®) in Follow-Up Patients with Non-Muscle Invasive Bladder Cancer and Cytological Diagnosis of Atypical Urothelial Cells—An Institutional Study

Peña

Riu

Hernández-Aguilera

et al. 2022

JCM

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“…New discoveries in the field of molecular bladder cancer subtypes can improve treatment pathways of bladder cancer patients, not only in the advanced urothelial disease, but also in non-muscle invasive disease initially treated with transurethral resections and BCG installations. In the near future, various anti-tumor agents will be added to the treatment (currently, pembrolizumab studies are most promising) [27][28][29].…”

Section: Discussionmentioning

confidence: 99%

A Personalized Approach to Radical Cystectomy Can Decrease Its Complication Rates

Adamczyk¹,

Pobłocki²,

Michalik

et al. 2022

JPM

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The aim of this study was to assess the influence of a patient’s general status on perioperative morbidity and mortality after radical cystectomy, and to assess which of the used scales is best for the prediction of major complications. The data of 331 patients with muscle-invasive bladder cancer, who underwent radical cystectomy, were analyzed. The general status was assessed according to the American Society of Anesthesiologists (ASA), Charlson Comorbidity Index (CCI), Eastern Cooperative Oncology Group (ECOG), and Geriatric-8 (G-8) scales. Complications were classified according to the Clavien–Dindo classification system. In a group of patients with the highest complication rate according to the Clavien–Dindo scale, (i) statistically more patients rated high according to the ASA and ECOG scales, (ii) patients had significantly higher CCI scores (minor complications (I-II), and (iii) there were significantly more patients rated as frail with G8—predominantly those with 11 points or fewer in the scale. A patient’s general status should be assessed before the start of therapy because patients with a high risk of death or serious complications (evaluated with any rating scale) should be offered conservative treatment. None of the scales can describe the risk of cystectomy, because the percentage of patients with major complications among those who achieved worse score results on any scale was not significantly different from the percentage of patients with major complications in the general group.

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“…77 Recent studies have found that the Bladder EpiCheck test has an overall sensitivity, specificity and NPV of 62.3%-91.67%, 82.06%-91.89% and 82.9%-97.14%, respectively and achieved a great improvement in sensitivity, specificity and NPV in the detection of high grade-BLCA (HG-BLCA) recurrence. [77][78][79][80][81][82][83] In addition to DNA methylation, DNA mutations could also provide new urine-based biomarkers for the surveillance of BLCA. 84 Mutations in TERT promoter occur in over 60% of BLCA.…”

Section: Residual Tumour and Monitor Recurrencementioning

confidence: 99%

Urine‐based liquid biopsy in bladder cancer: Opportunities and challenges

Wang

Jin

et al. 2023

Clinical and Translational Dis

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Bladder cancer (BLCA) is a most common urological tumours with high rate of recurrence, which needs long‐term of follow‐up. To date, diagnosis and surveillance of BLCA still rely on cystoscopy, an invasive and expensive method that increases the difficulty for routine follow‐up. Therefore, exploring new biomarkers or tests is an effective way to improve the current clinical management of BLCA. Recent years, liquid biopsy has received increasing attention, especially for its great potential for clinical application in the non‐invasive detection of tumours. In addition, liquid biopsy involves a wide range of biomarkers, including DNA, RNA, proteins, extracellular vesicles and metabolites in blood, urine or other body fluids. For BLCA, urine is a most ideal body fluid to achieve non‐invasive diagnosis and surveillance. Here, we address recent developments of urine‐based biomarkers or tests for clinical diagnostic challenges in BLCA, such as early detection, minimal residual, recurrence monitoring and therapeutic response. Meanwhile, the many challenges of urine biomarkers that need to be overcome are also discussed.

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Diagnostic performance of the Bladder EpiCheck methylation test and photodynamic diagnosis-guided cystoscopy in the surveillance of high-risk non-muscle invasive bladder cancer: A single centre, prospective, blinded clinical trial

Cited by 22 publications

References 22 publications

Usefulness of the Urine Methylation Test (Bladder EpiCheck®) in Follow-Up Patients with Non-Muscle Invasive Bladder Cancer and Cytological Diagnosis of Atypical Urothelial Cells—An Institutional Study

Usefulness of the Urine Methylation Test (Bladder EpiCheck®) in Follow-Up Patients with Non-Muscle Invasive Bladder Cancer and Cytological Diagnosis of Atypical Urothelial Cells—An Institutional Study

A Personalized Approach to Radical Cystectomy Can Decrease Its Complication Rates

Urine‐based liquid biopsy in bladder cancer: Opportunities and challenges

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