Design and Rationale of the ROGUE-1 Registry: A Multicentric Prospective Registry for Primary T1 Nonmuscle-invasive Bladder Cancer.
Academic Article
Overview
abstract
BACKGROUND AND OBJECTIVE: Patients with T1 nonmuscle-invasive bladder cancer (NMIBC) face substantial risks of recurrence and progression to muscle-invasive disease. However, current risk stratification tools rely on retrospective data with significant heterogeneity in the reporting of adverse pathological features. The ROGUE-1 registry was designed to address the unmet need for a clean, prospective dataset on primary T1 bladder cancer to enable accurate risk stratification and guide clinical decision-making. METHODS: ROGUE-1 is a multicentric, international, prospective registry enrolling 700 patients with a pathologically confirmed primary diagnosis of T1 bladder cancer across 18 urology centers in Europe and North America. All patients must have T1 disease confirmed at second-look transurethral resection of bladder tumor (TURB). Clinical, pathological, and epidemiological data are prospectively collected using an electronic case report form on the Castor electronic data capture platform. Central pathology review by expert genitourinary pathologists is performed for all specimens. An optional molecular component includes transcriptome analysis of formalin-fixed paraffin-embedded tumor specimens. The primary endpoints are therapy failure rates (recurrence, high-grade recurrence, and progression to muscle-invasive disease). Follow-up data are collected at 3-mo intervals. KEY FINDINGS AND LIMITATIONS: This is a protocol paper; no clinical results are reported. A key limitation is the observational design, which precludes treatment standardization across centers. The optional molecular component may result in variable specimen availability. CONCLUSIONS AND CLINICAL IMPLICATIONS: ROGUE-1 will provide a prospective, multi-institutional dataset to improve risk stratification in T1 NMIBC and identify patients who may benefit from early aggressive treatment versus conservative management. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05792033).
