BladderPath version 1
Research type
Research Study
Full title
Image Directed Redesign of Bladder Cancer Treatment Pathways
IRAS ID
210698
Contact name
Ana Hughes
Contact email
Sponsor organisation
University of Birmingham
ISRCTN Number
ISRCTN35296862
Duration of Study in the UK
8 years, 3 months, 2 days
Research summary
Bladder cancer treatment and outcomes have not changed significantly in 30 years. Standard management comprises local anaesthetic inspection of the bladder with a small endoscope. If a bladder tumour is seen, the patient then proceeds to general anaesthetic removal of the tumour via a larger, rigid cystoscope - transurethral resection of bladder tumour (TURBT). A major concern with the current pathway is that TURBT delays the definitive treatment - in the UK the typical delay from presentation to treatment is over 100 days. We believe that the prolonged pathway and potentially unnecessary TURBT may contribute to the poor outcomes seen with bladder cancer – around 50% will die of the disease within 5 years. We propose to test a modified pathway in which we would use flexible cystoscopy plus biopsy as initial assessment. The very small biopsy obtainable by this procedure is sufficient to confirm the presence of cancer and also the grade of tumour (high or low). Most muscle-invasive bladder cancer (MIBC) tumours are high grade. Non-muscle invasive bladder cancer (NMIBC) tumours may be high or low grade. The urologist can also assess the overall appearance of the tumour. Combining these factors, we can partition patients into probable NMIBC (low grade tumour, sea anemone-like appearance) and possible MIBC (high grade tumour, solid appearance). Probable NMIBC (around 50% of the total) would continue with current standard therapy. Those with possible muscle-invasion would proceed to MRI scan and be further separated into MIBC and NMIBC. Patients with no evidence of muscle-invasion would proceed to standard TURBT. Patients with evidence of muscle-invasion will proceed directly to definitive therapy, avoiding TURBT and reducing delay. Patients entering the trial would be randomly assigned to either the current standard pathway 1 or the image-directed pathway 2.
REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/1819
Date of REC Opinion
4 Dec 2017
REC opinion
Further Information Favourable Opinion