The EVOLVE England Study: Patients with La/m urotherial cancer
Research type
Research Study
Full title
The EVOLVE-England Study: A rEtrospectiVe database analysis Of the epidemiology, patient characteristics, treatment patterns, unmet need and resource utilisation in patients with Locally adVanced or mEtastatic urothelial cancer.
IRAS ID
303509
Contact name
John Were
Contact email
Sponsor organisation
Health iQ Limited
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Urothelial carcinomas (UCs) are the fourth most common tumours in developed countries. They can be located in the lower (bladder and urethra) and/or the upper (renal pelvis cavities and ureter) urinary tract. Bladder tumours account for 90-95% of UCs and are the most common urinary tract malignancy, while upper tract malignancies are less common and account for only 5-10% of all UCs.
Approximately 7% of patients present with disease that spreads to other areas of the body (locally advanced or metastatic -La/mUC) and are generally treated with chemotherapy and sometime surgery for patients with oligometastatic disease.
Patients with La/mUC have poor prognosis and may benefit from therapies with different mechanisms of action. Enfortumab vedotin, an antibody targeting the cell adhesion molecule nectin-4 linked to a microtubule inhibitor conjugate, has been approved in the United States for La/mUC patients is being targeted for submission in Europe.
However, there is a dearth of data on the epidemiology, treatment patterns and resource utilisation in patients with La/mUC in Europe, including the UK. No data has been identified which estimates the incidence and prevalence of La/mUC in the UK
This study aims to use pseudonymized data from Public Health England cancer and tumour registry (CAS) dataset to construct a group of patients with La/mUC. Using the same dataset linked to the cancer treatment datasets (systemic anticancer therapy or SACT, surgery in secondary care through the hospital episode statistics dataset or HES, radiotherapy through the radiotherapy dataset or RTDS), the study would determine patient characteristics and treatment pathways. The span of time covered would be from 2013 to the latest available data when it would be requested. Once completed, this study would hopefully inform health policy to reconfigure services to provide better treatment options and pathways for patients.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
21/SC/0265
Date of REC Opinion
2 Aug 2021
REC opinion
Favourable Opinion