Research trends for early cancer biomarker detection in Italy: An Integrated Program in Oncology (PIO) survey

Paolo Verderio, Anita Mangia, Claudio Orlando, Maurizio Belfiglio, Antonio Marchetti, Lucio Bertario, Gennaro Chiappetta, Massimo Gion, Gian Paolo Tonini, Franca Podo, Amina Vocaturo, Rosella Silvestrini, Claudio Lombardo, Angelo Paradiso, Sara Pizzamiglio, Massimo Romani, Elena Belloni, Delia Cavallo, Paola Ulivi, Stefania TommasiAgostino Steffan, Antonio Russo, Alessio Massimo, Daniele Calistri, Paola Parrella, Massimo Broggini, Antonio Giuseppe Naccarato, Fiamma Buttitta, Gaetano Finocchiaro, Giulia Veronesi, Lorena Landuzzi, Maria Benevolo, Luciano Mariani, Federico De Marco, Aldo Venuti, Gianluigi Giannelli, Michele Quaranta, Vito Trojano

Research output: Contribution to journalArticlepeer-review


Aims and background. In 2007, an Italian Research Network proposed to the Ministry of Health a concerted action aimed at developing a specific pathway for the analytical and clinical validation of new biomarkers for early cancer diagnosis. The action, funded by the Italian Ministry of Health within the Integrated Program in Oncology (PIO) and coordinated by the National Cancer Institute of Bari, started in 2008 involving 37 national research teams. Methods. To monitor the methodological and analytical needs of the studies proposed by the research teams of PIO as well as to explore the plausibility of planning external quality assessment programs for early cancer biomarker detection, the coordinating team developed an ad hoc questionnaire that was submitted to each research team. Results. From the collected data it emerged that about 70% of the biomarkers under investigation were analyzed according to nonroutine laboratory practices. The biological material utilized for biomarker assessment consisted of solid tissue (normal or pathological) in 31% of studies, serum in 21%, urine in 15%, plasma in 15%, and whole blood in 11%. Specific training of personnel directly involved in the program was reported by 18% of the teams. In 2008, only 6% of laboratories involved in PIO participated in both external quality assessment and internal quality control schemes specifically designed for the biomarkers under consideration. Standard operating procedures for the determination of about half (52%) of the biomarkers proved to be lacking in at least one phase of the biomarker assessment process. Conclusions. On the basis of these results, we decided to give priority to the application of a four-phase process for the analytical validation of new potential biomarkers by setting up and applying standard operating procedures and developing external quality assessment and internal quality control schemes as specific steps of the workflow. Free full text available at

Original languageEnglish
Pages (from-to)721-725
Number of pages5
Issue number5
Publication statusPublished - Sep 2010


  • Cancer biomarker
  • Italy
  • Survey

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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