ROGUE-1: Multicentric, prospective T1 BCa registry

29 October 2021 By Dr. David D'Andrea (see photo), Dr. Francesco Soria, Prof. Paolo Gontero, and Prof. Shahrokh Shariat

Patients with T1 urinary bladder cancer (UBC) are at high risk for recurrence and progression. [1] However, the prognosis depends on several concomitant factors. First and foremost, an accurate diagnosis is imperative to appropriate disease management.

Under or over-staging
Due to conventional transurethral resection techniques resulting in fragmentation and cauterisation of the tissue, the pathological review is often difficult and may result in under- or over-staging. A central pathology review of European Organisation For Research And Treatment Of Cancer (EORTC) trial data found only a 43% concordance in patients with T1 tumours. [2] Moreover, risk factors such as concomitant carcinoma in situ (CIS), variant histology (VH), and lymphovascular invasion (LVI) have been associated with a prognosis of a poor quality in patients with T1 UBC. [3] However, there is a consistent heterogeneity in reporting these features across studies.

Clean prospective dataset
There is an unmet need for a clean prospective dataset on T1 UBC to allow an accurate risk stratification in order to aid clinical decision making. Thanks to the support of the EAU Research Foundation (EAU RF), we could start a project aiming at prospectively collecting data on patients with a primary diagnosis of T1 UBC and creating a platform that will answer relevant clinical questions. Studies originating from this registry can potentially change risk stratification and, therefore, management of patients with T1 UBC.

Study objectives
The primary objectives of the study are:

  • To investigate the therapy failure rates in patients with primary diagnosis of T1 UBC;
  • To investigate the association of clinicopathological features such as LVI, VH and CIS, tumour size, and number of tumours with pathological outcomes;
  • To analyse the accuracy of the local pathologist assessment with regard to the evaluation of pathology features such as tumour stage and grade, sub-staging according to microscopical and extensive invasion, LVI, VH, and CIS;
  • To investigate the inter-observer variability among different local pathologists comparing these observations with a central pathology revision performed by an expert genitourinary pathologist;
  • To develop a clinically applicable risk stratification tool which may guide physicians during patient counselling and decision-making regrading adjuvant therapies or early cystectomy.

Patients with a primary diagnosis of UBC and who are scheduled for TURB are prospectively recruited from academic tertiary care centres across Europe, Canada, and the USA. Patients with confirmed diagnosis of T1 UBC are included in the study.

Adjuvant treatments
After TURB, patients will receive adjuvant treatments (i.e. intravesical therapy or early cystectomy) and a follow-up according to guidelines and clinical standards. All clinical and pathological data, as well as data regarding adjuvant treatments, will be prospectively collected during the study period or until patient death. We plan to recruit patients over a two-year period and follow them for five years. The duration of the project will therefore be seven years.

Complex data collection
One of the major challenges we faced when we planned this study was how to handle such an extensive and complex data collection. We needed a solution which was reliable, multi-platform and user-friendly. Thanks to the support of EAU RF, we could create an individualised, cloud-based clinical data management database for this project. We used the Castor Electronic Data Capture (www.castoredc. com), a platform developed to capture medical research data in clinical trials. The platform helps to standardise research studies and ultimately creates better treatments and care standards for patients.

Pathological images
Another major strength of this project is the prospective collection of pathological images. The database is designed to accept the upload and storage of scanned pathology slides that will be available for central pathological re-review and further analyses, as required by the projects originating from this database.

Failure rate
Recurrence rates for T1 bladder cancer are estimated to be up to 50%. [4] We plan to include 700 patients in the study. This allows detection of a 50% failure rate with 4% on either side of the 95% Confidence Interval (proportion 0,50 with 95% CI 0.46 – 0.54).

The recruitment of patients has started in August 2021. We are welcoming any partner interested in participating in this great project. We believe that this project has the potential of delivering high-quality data and a high level of evidence research that will eventually change the management of patients with T1 UBC.

For the reference list, please turn to page 29 of the August/September 2021 issue of European Urology Today.

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