Access to samples for development of new tests for bladder cancer
Research type
Research Study
Full title
The use of patient samples in the development and optimisation of new diagnostic tests to aid in the diagnosis, assessment of aggressiveness and monitoring of treatment of bladder cancer.
IRAS ID
195300
Contact name
Sarah Couch
Contact email
Sponsor organisation
Arquer Diagnostics Limited
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Arquer's intention is to develop simple, rapid, non-invasive tests that will help clinicians to make an assessment of the likelihood of patients having bladder cancer. In addition, Arquer are interested in developing tests that could be used during treatment for these cancers to monitor treatment success and recurrence of disease, and to look at further stratifying patients in terms of disease aggressiveness and progression. In order to conduct such research and development activity, Arquer may require from time to time access to urine samples from patients suspected or known to have bladder cancer, to optimise their kits and prove the principles established in the laboratory using model systems. Arquer would obtain these samples from patients attending outpatient clinics at Sunderland Royal Hospital. Suitable patients would be identified by clinical staff. They would be asked to allow the use of a portion of a routinely collected urine sample to be analysed by Arquer in their prototype assays for bladder cancer. Some clinical information on the presence and stage/severity of disease would also be collected. The results of the testing by Arquer will in no way influence the treatment of the patient, but will provide Arquer with proof of principle prior to full scale clinical performance evaluations. This will greatly improve Arquer's chances of success in developing clinically useful tests for future diagnosis and monitoring of bladder cancer. There will be no set recruitment period for this work, rather Arquer would propose that provision be made for occasional access to samples on an ongoing basis over no longer than 5 years to enable regular assessment of performance of prototype assays throughout the development process.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
16/WM/0203
Date of REC Opinion
26 Apr 2016
REC opinion
Favourable Opinion