BladderPath:Image Directed Redesign of Bladder Cancer Treatment Pathway

Image Directed Redesign of Bladder Cancer Treatment Pathway 

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Study Overview and Summary

BladderPath Trial Information
Chief Investigator: Professor Nicholas James
Sponsor: University of Birmingham
Funders: NIHR Health Technology Assessment (HTA)
Disease Site: Bladder Cancer
Study Type:

Randomised Phase II/III Clinical Study of a Non-Investigational Medicinal Product
Status: Closed to recruitment
UKCRN Study ID: (if applicable)  N/A
ISRCTN Referance Number: 35296862
Open to new sites? No
Recruitment start date:  31st May 2018
Recruitment end date 14th December 2021
CRCTU Study Management Team: Late Phase Trial Management Team A
Study E-mail Address: BladderPath@trials.bham.ac.uk

Study 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 study would be randomly assigned to either the current standard pathway 1 or the image-directed pathway 2.

Please note that the study team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.

Study Protocol

Clinical study protocols are complex technical documents which should only be used for the treatment of subjects taking part in the study. Patients who are interested in taking part in the study are advised to talk to their health care professional or refer to the CancerHelp website, see link below.

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference. 

Publications

This page will be updated with documents that might be helpful to patients and members of the public.

Journal Articles:

2023

V Nanton, (List not in order yet) Hughes AI, Pope AM, Jefferson K, Catto J, Knight A, Gallagher J, Mintz HP, Liu W, Pirrie SJ, Young A, Patel P, RT Bryan & James ND. Boosting and broadening recruitment to UK cancer trials: towards a blueprint for action. BMJ Onc. 2023;2: e000092 doi:10.1136/bmjonc-2023-000092

Mintz HP, Dosanjh A, Parsons H, Hughes A, Pope AM, Jakeman A, Liu W, Pirrie SJ, Brannan R, Hounsome L, Wu H, Sydes M, Carpenter J, Murray M, Ahmed S, Nanton V, Jefferson K, Catto J, Gallagher J, Knight A, Bryan RT, James ND, & Patel P. Making administrative healthcare systems clinical data the future of clinical trials: Lessons from BladderPath. BMJ Oncology 2023;2:e000038. Doi: dx.doi.org/10.1136/bmjonc-2023-000038

Baxter L, Bryan RT, Ward DG, The BladderPath trial management group, et al. Properties of non-coding mutation hotspots as urinary biomarkers for bladder cancer detection. Sci Rep; 13(1):1060. 19-Jan-2023 doi.org/10.1038/s41598-023-27675-4

2022

Ward DG, Baxter L, Ott S, Gordon NS, Want J, Patel p, Piechocki K, Silcock L, Sale C, Zeegers MP, Cheng KK, James ND, Bryan RT & BladderPath TMG. Highly Sensitive and Specific Detection of Bladder Cancer via Targeted Ultra-deep Sequencing of Urinary DNA. Euro Urol Oncol 6(1): 2023, pp 67-75. Published online 8-Apr-2022. doi.org/10.1016/j.euo.2022.03.005

2021

Bryan RT, Liu W, Pirrie SJ, Amir R, Gallagher J, Hughes AI, Jefferson KP, Knight A, Nanton V, Mintz HP, Pope AM, Catto JWF, Patel P & James ND. Comparing an Imaging-guided Pathway with the Standard Pathway for Staging Muscle-invasive Bladder Cancer: Preliminary Data from the BladderPath Study. Eur Uro Jnl July 2021 (Vol 80 (1)) (https://doi.org/10.1016/j.eururo.2021.02.021)

RT Bryan on behalf of The BladderPath trial management group. Reply to Trey Durdin, Alvin Goh, and Eugene Pietzak. Can an imaging-guided pathway replace the current paradigm for muscle-invasive bladder cancer? Euro Urology 80(1): 10-Jun-2021. doi.org/10.1016/j.eururo.2021.04.034

2020

Mintz HP, Dosanjh A, Hughes A, Jakeman A, James ND, Parsons HM, Pope AM & Patel P. Development and validation of a follow-up methodology for a randomised controlled trial, utilising routine clinical data as an alternative to traditional designs: a pilot study to assess the feasibility of use for the BladderPath trial. Pilot and Feasibility Studies Jnl (31-10-2020) 6:165 (-) Doi: 10.1186/s40814-020-00713-y

More information

Cancer Research UK