The Integrated Oncology Program of the Italian Ministry of Health Analytical and clinical validation of new biomarkers for early diagnosis: network,resources, methodology, quality control, and data analysis

摘要

In 2007, an Italian cancer research group proposed a specific concerted action aimed at the "analytical and clin-ical validation of new biomarkers for early diagnosis: Network, resources, methodology, quality control, and data analysis."The proposal united 37 national operative units involved in different biomarker studies and it created a strong coordinativebody with the necessary expertise in methodologies, statistical analysis, quality control, and biological resources to performad hoc validation studies for new biomarkers of early cancer diagnosis.The action, financed by the Italian Ministry of Health within the Integrated Oncology Program (PIO) coordinated by NCI-Istituto Tumori Bari, started in 2007 and activated 7 projects, each of which focused on disease-specific biomarker studies.Overall, the 37 participating units proposed studies on 50 biomarkers, including analytical and clinical validation proce-dures. Clusters of units were specifically involved in research of early-detection biomarkers for cancers of the lung, digestivetract, prostate/bladder, and nervous system, as well as female cancers. Furthermore, a cluster involved in biomarkers forbioimaging and infection-related cancers was created. The first investigators' meeting, "Analytical and clinical validation of new biomarkers for early diagnosis," was held on 9September 2008 in Bari. During this meeting, methodological aspects, scientific programs and preliminary results were pre-sented and discussed. (Int) Biol Markers 2009; 24: 119-29)