INVASIVE UROTHELIAL BLADDER CARCINOMA-SURVIVAL RATE STUDY-2
Research type
Research Study
Full title
DESCRIBING OVERALL SURVIVAL AND FIRST-LINE TREATMENT PATTERNS IN HIGH-RISK INVASIVE UROTHELIAL BLADDER CARCINOMA POST-RESECTION PATIENTS Data Sourcing and Delivery
IRAS ID
333784
Contact name
Simon Crabb
Contact email
Sponsor organisation
BC Platforms
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
The study titled "Describing overall survival and first-line treatment patterns in high-risk invasive urothelial bladder carcinoma post resection patients" focuses on urothelial bladder carcinoma, which accounts for a significant portion of global bladder cancer cases. Bladder cancer constitutes 3% of global cancers, with over 90% of cases arising from urothelial cells. In 2018, approximately 550,000 people were diagnosed with bladder cancer, contributing to 2.1% of all cancer-related deaths.
Notably, urothelial bladder carcinoma exhibits gender-based disparities, with males being at higher risk due to factors like occupational exposure and smoking habits, although these trends have evolved over time. Moreover, females often receive diagnoses at more advanced stages, potentially leading to reduced chances of curative therapy.
The study aims to describe the overall survival of high-risk, invasive urothelial carcinoma patients post-surgery and investigate treatment patterns. It also explores factors such as TNM stage, histology, age group, and systemic anti-cancer therapy regimens received.
Hematuria, the most common symptom of urothelial bladder carcinoma, is a key factor in early diagnosis. However, non-visible hematuria poses diagnostic challenges due to varying definitions across healthcare systems.
Before 2016, standard care for urothelial bladder carcinoma involved trans-urethral resection of the bladder tumor, with systemic chemotherapies reserved for advanced or metastatic cases. Systemic therapies were used in conjunction with local therapies to reduce recurrence.
The study employs real-world patient-level data from various countries and regions, such as the UK, Nordics, Spain, Portugal, France, and Italy, to achieve its objectives. Data sources include demographics, diagnosis details, comorbidities, treatment history, and outcomes. The analysis will be descriptive, with statistics presented in tabular and graphical formats.
The study's sample size is estimated at 320 patients, with data collected from 2013 to 2023. The research findings may be used for publications to describe the study's objectives and research intention.
REC name
HSC REC B
REC reference
23/NI/0164
Date of REC Opinion
27 Nov 2023
REC opinion
Favourable Opinion