NRAS-BRAF Clinical Performance Evaluation Study
Research type
Research Study
Full title
NRAS-BRAF Clinical Performance Evaluation Study
IRAS ID
197102
Contact name
Louise Johnston
Contact email
Sponsor organisation
Biocartis NV
Duration of Study in the UK
0 years, 1 months, 6 days
Research summary
Biocartis is developing a new test to detect changes in tumour samples taken from patients with colorectal cancer. These changes can help inform and direct treatment decisions. For example, if a particular change is detected in a patient’s tumour sample, the clinician would not administer certain drugs to that patient because there is a high chance that the drug will not be beneficial. On the other hand, if no change is detected in the tumour sample, the drugs may be administered as they are likely to be beneficial in that patient. Therefore, the ability to test a tumour sample for the presence of particular change can ensure the patient receives the right therapy as quickly as possible.
In this study, we plan to look at Biocartis’ new test (Idylla NRAS-BRAF mutation test). This test has been designed to detect specific changes in tumour samples taken from patients with colorectal cancer within the last 10 years. These old tumour samples are stored in the pathology laboratory at the Royal Victoria Infirmary in paraffin blocks as part of routine care.
The new test result will be compared to the old test result that was generated at the time the sample was originally collected. This is called a performance evaluation study. This study will run for approximately one month. The results that are generated by this study will not be used for clinical purposes and they will not influence patient care. No patient details will be shared with researchers.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/0509
Date of REC Opinion
18 Mar 2016
REC opinion
Further Information Favourable Opinion