|The primary objective of the study is to investigate the ability of the UroMark, a urinary based test, to detect bladder cancers across a spectrum of stage and grade of disease. The secondary objective is the determine if UroMark can detect tumour recurrence during the surveillance period after transurethral resection of bladder tumour (TURBT). A qualitative assessment to understand patient acceptance of a urinary based biomarker as an alternative or combined with cystoscopy (direct inspection of the bladder) in cohort of patients undergoing surveillance cystoscopy will also be performed. The UroMark is currently undergoing late phase validation and will analyse DNA from cells present in urine.
Men and women ≥18 years who have a cystoscopic confirmation of bladder tumour will be recruited into the trial. The subjects will be consented to provide a control urine sample in clinic, which is part of standard of care, as well as urine sample collected at home using a UroMark kit which will be posted to the laboratory. A home urine sample will also be collected prior to each surveillance cystoscopy which will be performed in accordance to NICE guidance.
Subjects will also complete a questionnaire. Patients will be followed-up for 24 months.
This study is a prospective observational study without any intervention. It is expected that there will be minimal ethical, legal or management issues. Lay-persons who are typical of the subjects who might be recruited have been consulted in developing this proposal.
Home urine collection is straight forward. Urine collection can be performed at anytime. The questionnaire will be straight forward.
Prospective subjects will be identified from flexible cystoscopy clinics or pre-assessment clinics for patients going to have a transurethral resection of bladder tumour (TURBT). A clinician can obtain verbal consent from the subject which will be documented in the medical notes. Written consent can be obtained at a later stage if the subject is happy to
participate. Home urine collection can be posted back to the receiving laboratory. Subjects will be contacted at 3 monthly intervals for 24 months to inform them that a UroMark kit will be posted to them for them to send back for urine collection.
With respect to confidentiality, we will follow the ‘Caldicott Principles’ as implemented by UCL (study sponsor).
|A Phase II, open label, multi-centre, randomised controlled trial comparing Hyperthermia plus Mitomycin to Mitomycin alone in patients with Intermediate risk non-muscle invasive bladder cancer.
Study method and design
This is an open-label, multi-centre, randomised controlled trial comparing hyperthermia plus mitomycin (HM) to mitomycin (MM) in patients with new or recurrence of intermediate-risk non-muscle invasive bladder cancer.
Disease recurrence is defined as detection of intermediate risk NMIBC (Ta,T1) grade G1 or G2 disease without CIS. Standard adjuvant MM is defined as an immediate post-operative single instillation of MM followed by 6 weekly instillations of MM.
The primary outcome measures will be disease-free survival at 24 months. Secondary outcome measures will include recurrence at three months, overall and disease-specific survival in all patients, and recurrence-free survival in patients with papillary disease. The safety and tolerability of HIVEC will be assessed and compared to MM. QOL will be assessed in all patients at randomisation and at 3, 6 and 12 months in patients receiving HIVEC and MM
|CALIBER is a phase II, multicentre, randomised controlled trial (RCT). A control group has been included to provide prospective data about surgical management and outcomes and assess feasibility of recruitment to a randomised study.
Patients assigned to the chemoresection group will receive 4 once weekly intravesical instillations of 40mg MMC as outpatients.
Patients assigned to the surgical management group will receive the standard surgical management in use at their hospital for treatment of recurrence which may include a single post-operative installation of 40mg MMC within 24 hours.
All participants will be followed up at 3 weeks from the start of treatment (i.e. at time of final MMC instillation for chemoresection group) and each will receive a cystoscopy three months from the end of treatment to assess response, in accordance with EAU guidelines. Subsequent cystoscopic follow up will take place 12 months after treatment if recurrence-free at 3 months and then annually.