Pre-trial inter-laboratory analytical validation of the FOCUS4 personalised therapy trial

Journal of Clinical Pathology
Susan D RichmanFOCUS4 Trial Management Group

Abstract

Molecular characterisation of tumours is increasing personalisation of cancer therapy, tailored to an individual and their cancer. FOCUS4 is a molecularly stratified clinical trial for patients with advanced colorectal cancer. During an initial 16-week period of standard first-line chemotherapy, tumour tissue will undergo several molecular assays, with the results used for cohort allocation, then randomisation. Laboratories in Leeds and Cardiff will perform the molecular testing. The results of a rigorous pre-trial inter-laboratory analytical validation are presented and discussed. Wales Cancer Bank supplied FFPE tumour blocks from 97 mCRC patients with consent for use in further research. Both laboratories processed each sample according to an agreed definitive FOCUS4 laboratory protocol, reporting results directly to the MRC Trial Management Group for independent cross-referencing. Pyrosequencing analysis of mutation status at KRAS codons12/13/61/146, NRAS codons12/13/61, BRAF codon600 and PIK3CA codons542/545/546/1047, generated highly concordant results. Two samples gave discrepant results; in one a PIK3CA mutation was detected only in Leeds, and in the other, a PIK3CA mutation was only detected in Cardiff. pTEN and mismatc...Continue Reading

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Citations

Jul 10, 2018·Applied Immunohistochemistry & Molecular Morphology : AIMM·Sarah WeddenCorrado D'Arrigo
May 30, 2019·Trials·Francesca SchiavoneUNKNOWN past and present members of the STAMPEDE and FOCUS4 Trial Management Group
Jul 18, 2021·Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology·Josien C A JenniskensHeike I Grabsch
Nov 19, 2021·The Journal of Pathology. Clinical Research·Kelly OffermansPiet A van den Brandt

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Methods Mentioned

BETA
biopsy
biopsies
Assay

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