Angiogenesis Assay Validation (version1)
Research type
Research Study
Full title
Clinical and analytical validation of a diagnostic assay to predict response to bevacizumab in high grade serous ovarian cancer and metastatic colorectal cancer.
IRAS ID
165384
Contact name
Joy Kavanagh
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 an assay that may have prognostic and predictive value in oncology. A 63-gene signature has been generated from microarray analysis of high grade serous ovarian cancer (HGSOC) tumour samples, namely the AADx signature. This signature identifies patient groups who have a better prognosis following standard chemotherapy treatment. The AADx signature was also shown to have predictive utility for identifying patients who will derive benefit from the combination of the anti-angiogenic drug bevacizumab (Avastin, Roche®) with standard chemotherapy. This was demonstrated by clinical validation of the AADx gene signature in ovarian cancer tissue samples collected from patients recruited to the ICON7 clinical trial. The results of the ICON7 trial showed that bevacizumab in combination with standard of care chemotherapy improved the progression free survival of ovarian cancer patients by an average of 9.4 months longer than patients that received chemotherapy alone.
The first objective of this research is to further analytically and clinically validate the prognostic and predictive utility of the AADx signature in independent cohorts of tissue obtained from HGSOC patients.
The second objective of this study is to evaluate the prognostic and predictive utility of the AADx signature in the metastatic colorectal cancer (mCRC) setting. If the utility of the AADx signature is validated within the mCRC setting then the signature will be further analytically validated for use as a diagnostic assay within this disease indication.
The proposed outcome of this research will be the availability of a clinically and analytically validated diagnostic assay that can provide prognostic and predictive information that will inform the clinical management of advanced ovarian and colorectal cancer patients. This diagnostic assay would ultimately prevent unnecessary exposure of patients predicted by the AADx assay as non-responders to the side-effects of bevacizumab.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0145
Date of REC Opinion
20 Mar 2015
REC opinion
Favourable Opinion