BladderPath: For Investigators

Image Directed Redesign of BladderCancer Treatment Pathways

 

For copies of the latest and previous versions of documents distributed for this trial, please contact the BladderPath Trial Office at BladderPath@trials.bham.ac.uk.

Change of Staff

If there is a change of staff working on the study please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. Return both documents to the BladderPath Study Office.

  • Site Staff Registration Form [PDF 146kb]
  • Investigator Registration Form [PDF 149kb]
  • Site Signature and Delegation Log [PDF 37kb]
  • Training Log [PDF 69kb]

Study Documents

Links to the current protocol, patient information sheet, informed consent form are provided below. If there has been a recent amendment to the study please ensure you have R&D approval before using these documents.

Other documents (e.g. amendments, case report form, serious adverse event Form, guidelines, GP Letter etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the BladderPath Study Office.

Version Control Lists

The version numbers and dates of all documents currently used for the study are captured on a document version control lists below:

  • ISF Main Documents Version Control List V6a 27-Aug-2020 [PDF 280kb]
  • ISF Main Documents Version Control List V17 13-Dec-2021 [PDF 15kb]
  • ISF Main Documents Version Control List V18 8-Feb-2023 [PDF 15kb]
  • ISF Main Documents Version Control List V19 4-Mar-2023 [PDF 15kb]

Case Report Form

Links to the current CRF are provided below.

  • Eligibility Checklist [PDF 148kb]
  • Registration Form [PDF 433kb]
  • Randomisation Form [PDF 459kb]
  • Flexible Cytoscopy Form [PDF 394kb]
  • Pathology Form [PDF 179kb]
  • Baseline Form [PDF 521kb]
  • MRI Form [PDF 400kb]
  • TURBT Form [PDF 618kb]
  • Staging Form [PDF 392kb]
  • Sytemic Chemotherapy Form [PDF 383kb]
  • Radiotherapy Form [PDF 405kb]
  • Cystectomy Form [PDF 395kb]
  • Intravesical Therapy Form [PDF 393kb]
  • End of Intravesical Therapy Form [PDF 380kb]
  • Recurrence & Progression Form [PDF 482kb]
  • Withdrawal of Consent Form [PDF 396kb]
  • Deviation Form [PDF 392kb]
  • Follow-up Form [PDF 162kb]
  • Death Form [PDF 393kb]

Newsletters

  • Issue 1 Dec 2018 [PDF 861kb]
  • Issue 2 April 2019 [PDF 980kb]
  • Issue 3 July 2019 [PDF 597kb]
  • Issue 4 Feb 2020 [PDF 951kb]
  • Issue 5 Oct 2020 [PDF 578kb]

Guidelines

Other Study Documents

  • SAE Form [PDF 459kb]
  • Questionnaires Booklet [PDF 592kb]
  • Patient Screening Enrolment Log [PDF 28kb]

Publications

 Journal Articles: 

2024

James ND, Pirrie SJ, Liu W, Catto JG, JeffersonK, PatelP, Hughes A, Pope AM, Nanton V, Mintz HP, Knight A, Gallagher J, Bryan RT. Image directed redesign of bladder cancer treatment pathways: the BladderPath RCT. NIHR Health Technology Assessment 28(42) 29-Aug-2024 https://doi.org/10.3310/DEHT5407

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

News and Events

There is no current news or events for this study.

Contact Details

Chief Investigator

Professor Nicholas James                                          
The Institute of Cancer Research (ICR), London                                              

BladderPath Study Office

Cancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham B15 2TT

Trial Management Team Leader: 

Sophia Magwaro

Enquiries

Email: BladderPath@trials.bham.ac.uk

Serious Adverse Event Reporting

All SAE reports or follow-up reports must be emailed to reg@trials.bham.ac.uk