DETECT II

• Research type

  Research Study

• Full title

  A multi-centre observational study design to determine the sensitivity of the UroMark assay, a urine test, to detect new and recurrent low, intermediate and high grade bladder cancer.

• IRAS ID

  203022

• Contact name

  John Kelly

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  Z6364106/2016/04/31, UCL Data Protection Registration Number

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  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.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  16/LO/1044

• Date of REC Opinion

  20 Jul 2016

• REC opinion

  Further Information Favourable Opinion