Study of BCG-treated bladder cancer patients
Research type
Research Study
Full title
Bladder cancer patients treated with BCG instillation in England: their characteristics, treatment pattern, outcomes, health resource utilisation, and cost burden.
IRAS ID
276426
Contact name
Artak Khachatryan
Contact email
Sponsor organisation
Certara- Evidence and Access (also known as Analytica Laser, a Certara company)
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
In Europe, the age-standardised incidence rates for bladder cancer were estimated at 19.1/100,000 for men and 4.0/100,000 for women(Ferlay et al.,GLOBOCAN 2012 v1.0). Non-muscle bladder cancer (NMIBC) is the term commonly used to describe tumours diagnosed at an early stage where the malignant growth shows no evidence of involvement of the deeper detrusor muscle layer or other loco-regional or distant anatomical sites. These tumours represent 75% of bladder tumours. The treatment of NMIBC usually involves tumour resection, which may be followed by intravesical immunotherapy with Bacillus Calmette–Guérin (BCG) or indicated chemotherapy. Treatment failure with BCG was previously estimated to range between 40 and 50% (Sylvester et al., Eur Urol.;49:466–5 2006). This information is based on seven clinical trials performed between 1979 and 1989.
This retrospective cohort study aims to describe the clinical characteristics, disease background, and current treatment patterns of patients diagnosed with NMIBC and treated with BCG in England. This study will also explore how treatment or other data, without drawing on staging and grading information, can be utilised to identify patients with NMIBC and MIBC. The study population will be derived from the National Cancer Registration and Analysis Service (NCRAS) which is a collection of linked national datasets covering cancer registrations, systemic antineoplastic therapies, radiotherapies, and hospital episode statistics (including any procedures) on the utilisation of health care within the National Health Service (NHS) of England. A total of 43,056 patients with NMIBC diagnosis is estimated to be identified between 2013 and 2017 (Cancer Research UK, 2019). A third of these cases, 14,352, is estimated to have received BCG instillation, and of those, 1,722 patients would be estimated to have failed BCG based. The overall observation period, including baseline and maximum follow up time, will start from 1st January 2008 and will end on 31st March 2018.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0126
Date of REC Opinion
5 May 2020
REC opinion
Favourable Opinion