Study Title: A multicentre 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.
Short Title: DETECT II
DETECT II is a multicentre observational diagnostic study to assess the performance of the UroMark assay to detect bladder cancer across a spectrum of stage and grade of disease. The study will recruit consecutive patients attending haematuria clinics as well as patients referred to the check cystoscopy clinics.
Consenting patients will provide a urine sample when they join the study and asked to provide further samples every 3 months prior to each surveillance cystoscopy, up until 24 months from home.
We aim to recruit 400 patients onto this study. The standard of care assessments will be performed as usual for this disease group and the results will be used to confirm whether it is bladder cancer and their stage and grade.
Patients will be followed-up in the study for 24 months. In addition, the participants will be asked to complete a simple questionnaire. With the exception of the urine sample that will be provided by patient from home and the questionnaire all treatment and assessments are according to standard care.
Sponsor: University College London
Funder: Medical Research Council
ClinicalTrials.gov Identifier: NCT02781428