DETECT I
Research type
Research Study
Full title
A prospective observational study to determine the negative predictive value of UroMark to rule out the presence of bladder cancer in patients with haematuria.
IRAS ID
179245
Contact name
John Kelly
Contact email
Sponsor organisation
UCL
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Z6364106/2015/10/02, UCL Data Protection Registration Number
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
We are investigating whether the test called UroMark can detect bladder cancer in patients who are being investigated for haematuria. UroMark is currently in development stage and early results indicate that it can detect bladder cancer with a high degree of certainty. The test detects changes in the DNA of cells which are present in urine. Changes in DNA, called mutations or epigenetic alterations, are present in cells collected from a urine sample if cancer is present. We would like to understand if the UroMark test can detect bladder cancer.
We will contact men and women who have been referred to hospital to have tests because of the finding of either visible or non-visible blood in the urine. Everyone who agrees to take part will be receiving the normal investigations for haematuria.
Subjects will be asked to provide two urine samples and complete a brief questionnaire. This will end their participation in the study. One urine sample is part of standard care, one is an additional sample for the UroMark assay which will be posted by patient.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0150
Date of REC Opinion
9 Mar 2016
REC opinion
Further Information Favourable Opinion