Abstract
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 www.tumorionline.it.
| Original language | English |
|---|---|
| Pages (from-to) | 721-725 |
| Number of pages | 5 |
| Journal | Tumori |
| Volume | 96 |
| Issue number | 5 |
| Publication status | Published - Sep 2010 |
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Keywords
- Cancer biomarker
- Italy
- Survey
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Research trends for early cancer biomarker detection in Italy : An Integrated Program in Oncology (PIO) survey. / Verderio, Paolo; Mangia, Anita; Orlando, Claudio; Belfiglio, Maurizio; Marchetti, Antonio; Bertario, Lucio; Chiappetta, Gennaro; Gion, Massimo; Tonini, Gian Paolo; Podo, Franca; Vocaturo, Amina; Silvestrini, Rosella; Lombardo, Claudio; Paradiso, Angelo; Pizzamiglio, Sara; Romani, Massimo; Belloni, Elena; Cavallo, Delia; Ulivi, Paola; Tommasi, Stefania; Steffan, Agostino; Russo, Antonio; Massimo, Alessio; Calistri, Daniele; Parrella, Paola; Broggini, Massimo; Naccarato, Antonio Giuseppe; Buttitta, Fiamma; Finocchiaro, Gaetano; Veronesi, Giulia; Landuzzi, Lorena; Benevolo, Maria; Mariani, Luciano; De Marco, Federico; Venuti, Aldo; Giannelli, Gianluigi; Quaranta, Michele; Trojano, Vito.
In: Tumori, Vol. 96, No. 5, 09.2010, p. 721-725.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Research trends for early cancer biomarker detection in Italy
T2 - An Integrated Program in Oncology (PIO) survey
AU - Verderio, Paolo
AU - Mangia, Anita
AU - Orlando, Claudio
AU - Belfiglio, Maurizio
AU - Marchetti, Antonio
AU - Bertario, Lucio
AU - Chiappetta, Gennaro
AU - Gion, Massimo
AU - Tonini, Gian Paolo
AU - Podo, Franca
AU - Vocaturo, Amina
AU - Silvestrini, Rosella
AU - Lombardo, Claudio
AU - Paradiso, Angelo
AU - Pizzamiglio, Sara
AU - Romani, Massimo
AU - Belloni, Elena
AU - Cavallo, Delia
AU - Ulivi, Paola
AU - Tommasi, Stefania
AU - Steffan, Agostino
AU - Russo, Antonio
AU - Massimo, Alessio
AU - Calistri, Daniele
AU - Parrella, Paola
AU - Broggini, Massimo
AU - Naccarato, Antonio Giuseppe
AU - Buttitta, Fiamma
AU - Finocchiaro, Gaetano
AU - Veronesi, Giulia
AU - Landuzzi, Lorena
AU - Benevolo, Maria
AU - Mariani, Luciano
AU - De Marco, Federico
AU - Venuti, Aldo
AU - Giannelli, Gianluigi
AU - Quaranta, Michele
AU - Trojano, Vito
PY - 2010/9
Y1 - 2010/9
N2 - 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 www.tumorionline.it.
AB - 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 www.tumorionline.it.
KW - Cancer biomarker
KW - Italy
KW - Survey
UR - http://www.scopus.com/inward/record.url?scp=78650491857&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=78650491857&partnerID=8YFLogxK
M3 - Article
C2 - 21302619
AN - SCOPUS:78650491857
VL - 96
SP - 721
EP - 725
JO - Tumori
JF - Tumori
SN - 0300-8916
IS - 5
ER -