A Plea for the Use of Video-recorded Cystoscopy for Blinded Independent Central Review of Tumor Response in Open-label Non-muscle invasive Bladder Cancer Trials

Giuseppe Basile; Benjamin Pradere; Joaquim Bellmunt; Morgan Rouprêt; Ashish M Kamat; Thomas Seisen

doi:10.1016/j.euo.2023.07.005

A Plea for the Use of Video-recorded Cystoscopy for Blinded Independent Central Review of Tumor Response in Open-label Non-muscle invasive Bladder Cancer Trials

Eur Urol Oncol. 2023 Oct;6(5):453-455. doi: 10.1016/j.euo.2023.07.005. Epub 2023 Aug 19.

Authors

Giuseppe Basile¹, Benjamin Pradere², Joaquim Bellmunt³, Morgan Rouprêt⁴, Ashish M Kamat⁵, Thomas Seisen⁶

Affiliations

¹ Department of Urology, IRCCS San Raffaele Hospital, Milan, Italy.
² Department of Urology UROSUD, La Croix Du Sud Hospital, Quint Fonsegrives, France; Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
³ Department of Medical Oncology, Dana-Farber Cancer Center and IMIM Research Lab, Harvard Medical School, Boston, MA, USA.
⁴ Department of Urology, Pitié-Salpêtrière Hospital, AP-HP, GRC 5 Predictive Onco-Urology, Sorbonne University, Paris, France.
⁵ Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁶ Department of Urology, Pitié-Salpêtrière Hospital, AP-HP, GRC 5 Predictive Onco-Urology, Sorbonne University, Paris, France. Electronic address: [email protected].

PMID: 37604762
DOI: 10.1016/j.euo.2023.07.005

Abstract

Given that most of non-muscle invasive bladder cancer trials available in the literature share the same limitation of an open-label design, they are likely prone to detection bias. Indeed, tumor response is currently assessed by unblinded investigators, mainly via follow-up cystoscopy, which has well-known intraobserver and interobserver variability. Thus, we believe that the use of video-recorded cystoscopy for blinded independent central review of tumor response could help to minimize detection bias in open-label NMIBC trials.

Publication types

Editorial

MeSH terms

Clinical Trials as Topic
Cystoscopy* / methods
Humans
Neoplasm Invasiveness
Non-Muscle Invasive Bladder Neoplasms
Observer Variation
Urinary Bladder Neoplasms* / diagnosis
Urinary Bladder Neoplasms* / pathology
Video Recording*