Assay Validation for Receptor Tyrosine Kinase Inhibitor Treatment V1
Research type
Research Study
Full title
Clinical and analytical validation of diagnostic assays for Receptor Tyrosine Kinase Inhibitor treatment in Cancer.
IRAS ID
213418
Contact name
Richard Kennedy
Contact email
Sponsor organisation
Almac Diagnostics
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The purpose of this research is to validate the clinical utilities of the Almac Diagnostic Tests for use in oncology. These gene expression signature assays are currently in development at Almac and have demonstrated prognostic (indicates the likely outcome of disease) and/or predictive (predicting the response to a particular therapy) value in the context of standard-of-care cancer treatment and/or targeted therapy approaches in a range of oncology indications.
Preclinical studies using the Almac Diagnostic Tests have indicated their predictive utility for treatment with Receptor Tyrosine Kinase inhibitors (RTKi). An assessment of the performance of the Almac Diagnostic Tests using tumour samples from patients treated with these drug agents, is necessary to confirm the relevance of the Tests in the RTKi setting. This will further underpin assay clinical utility. The overall objective of this study is the development of commercial Diagnostic Tests that have been rigorously clinically and analytically validated. The benefits of such tests are significant: Firstly, patients that will respond to RTKi will be selected directing these individuals through this course of treatment with an anticipated good outcome. Secondly, the Tests will identify patients that will not benefit from RTKi, directing such individuals on an alternative course of treatment that will have an expected better outcome than RTKi treatment. The ultimate advantage of using Diagnostic Tests is to inform the clinical team responsible for the management of an individual’s disease. Consequently, this will minimise the administration of treatments to patients with no rationale, prevent unnecessary side-effects of RTKi as not all cancer patients respond to these agents and reduce the observation time for patients and clinicians with respect to treatment response, if any. As well as patient benefits, the resultant cost saving to healthcare will be substantial.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0264
Date of REC Opinion
23 Aug 2016
REC opinion
Favourable Opinion