The clinical study approved by ethics committees and registered in clinicaltrials.gov of participating hospitals is progressing. A total of 1086 retrospective and 451 prospective patients have been enrolled for whom clinical/medical, pathology, treatment, toxicity and follow-up data have been collected, along with diagnostic images and genomic profiles extracted from relevant biological specimens. These data have been used to validate already published prognostic models and related signatures and to validate a newly identified genomic signature for oral cavity cancer (to be patented). Population data (cancer registries for 5 EU Countries and socio-economic, lifestyle, environmental data) have been collected and used for model recalibration and big data analysis. HPV study on oropharynx (N=1200) oral cavity (N>1000) cancer cases was conducted at VUMC leading to a new method for HPV analysis. Software for features extraction and semi-automatic tumor delineation in CT and MRI scans has been produced and successfully used during the project. Certification pathways for the developed tools were defined. A co-decision aid involving patients in treatment decisions has been produced in Dutch, English and German language for challenging larynx cancer and verified by physicians, patients and ethics experts. The clinical assessment has shown that BD2Decide prognostic algorithms improve TNM at least by 10% for HNC. Effects on quality of life were also analyzed showing possible improvements. A complete ontology for HNC data annotation was developed and implemented. A Visual Analytics Tools for data query and simulations is available for data analysis and research. A secure and privacy-preserving Big Data Infrastructure has been deployed to store and manage all the collected data and images. Large dissemination was conducted with 43 published papers, 4 conferences and 3 workshops organized, reaching more than 17000 researchers in the scientific community, more than 1000 industrial representatives, more than 4000 representatives of the civil society, 205 policy makers, 45 investors, 105 media, and more than 50.000 citizens in the general public. The project logo, website and presence in social media was established in the first months of the project. From the project start the website had a 4426 visits from 2805 users. The prospect market has been sized, IPRs have been defined, exploitation intentions defined. The project achieved all the expected objectives and realized the largest HNC dataset in Europe.
