WP1

Creation, development and maintenance of ENSAT-HT clinical data capture model. Creation and maintenance of online registry supporting data capture, biomaterial transfer inventory and connection to ENSAT registry. Advanced functionality includes a registry-connected Quality of Life mobile app, development of pairing algorithm for secondary study, the bulk upload of extended retrospective clinical data. Consent from all collaborators on data sharing protocols has been achieved. A Research Data Management Platform (RDMP) has been deployed and populated with 5 omics datasets recently provided by collaborators along with its provenance. Procurement, installation and configuration of infrastructure and hardware, for hosting omics data within Safe Heaven environment have been realised. A systematic review of machine learning algorithms for omics dataset and study various prospective techniques has been undertaken. Different processing pipelines for omics data management have been supported. Representative omics data is used to study the impact of feature sub-selection on the classification accuracy of phenotypes. Single omic and preliminary multi-omics analysis is currently underway.

There have been a number of highly productive scientific exchanges within WP2.  Work has been presented at national and International conferences and high-impact factor publications acknowledging ENSAT-HT have been produced.  Commercialisation of some of the techniques for genotyping is also underway. 

Blood and urine samples were collected from 3327 patients , including the 482 ENSAT-HT core samples, and analysed for different selections of biomarkers using advanced measurement methods that involved measurements in each sample from a minimum of 4 different potential biomarkers to many thousands of potential biomarkers per specimen. Use of only 2 types of metabolomics-derived measures allowed already to identify a panel of 14 biomarkers that could correctly classify 91% of patients with different forms of endocrine hypertension compared to primary hypertension.

Development of protocol, medical-ethical approval and start of recruitment.  

We undertook a review of omics assessment methods used by the main HTA bodies - national public agencies, other public and private organizations -, in order to identify the evidence required, in terms of criteria used and methods applied. Only multi-analyte assays with algorithmic analyses (MAAA), cancer and non-cancer, non-companion (stand-alone) tests that are actionable and have been evaluated by at least one HTA body until May 2016 were included. Twenty-five reports and articles have been finally taken into account regarding 17 MAAAs. As assessment criteria, clinical validity and clinical utility were largely used, as well as economic, ethical, legal and social aspects. The two main models used were the EUnetHTA Core model or the ACCE framework, which could be adapted to the assessment of MAAAs. The work was consolidated and validated with EUnetHTA.

In period 2 the website was regularly updated with photos, publications and results of the consortium. A graphic video on ENSAT-HT was produced and disseminated on the partners’ network. The first contact for the Industrial Management Board were initiated.

In period 2 WP 7 monitored the progress of all the WPs, followed-up the distribution of funds , organised the meetings of the consortium and ExCom and assisted partners individually on any administrative or legal and financial questions related to the EC rules.