Verification of urinary detection test in patient with haematuria
Research type
Research Study
Full title
Verification of urinary Xpert bladder cancer detection test in patients with haematuria
IRAS ID
273366
Contact name
Ghulam Nabi
Contact email
Sponsor organisation
University of Dundee
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
The trial hopes to develop new methods for diagnosing bladder cancer. Current methods for detecting bladder cancer are very effective for more obvious changes but are not very sensitive for early and subtle changes, or for deep lying cancers. Bladder cancer is currently associated with high rates of recurrence and progression, partly due to the inability to detect and deal with cancer early on. The purpose of this trial is to evaluate the function and accuracy of a new diagnostic system for detecting bladder cancer related biomarker mRNAs from the left-over urine. The method involves analysing 5 target biomarkers mRNAs in the urine with Cepheid GeneXpert® Instrument Systems that detects specific biomarkers found in cancer patients’ urine. The information obtained from this trial will be in the form of POSITIVE or NEGATIVE test results. If successful, the data generated will inform the design of a technique which could reinforce the current recommended procedures for bladder cancer diagnosis. It is worth stressing that this technique will have no effect on the subsequent “gold standard” analysis of the samples which currently happens in the NHS.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0040
Date of REC Opinion
23 Jun 2020
REC opinion
Further Information Favourable Opinion