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.
In 2007, an Italian cancer research group proposed a specific concerted action aimed at the "analytical and clinica 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 coordinative body with the necessary expertise in methodologies, statistical analysis, quality control, and biological resources to perform ad 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 procedures. Clusters of units were specifically involved in research of early-detection biomarkers for cancers of the lung, digestive tract, prostate/bladder, and nervous system, as well as female cancers. Furthermore, a cluster involved in biomarkers for bioimaging and infection-related cancers was created. The first investigators' meeting, "Analytical and clinical validation of new biomarkers for early diagnosis," was held on 9 September 2008 in Bari. During this meeting, methodological aspects, scientific programs and preliminary results were presented and discussed.
Paradiso
Angelo
A
National Cancer Institute Giovanni Paolo II, Bari, Italy. a.paradiso@oncologico.bari.it
Mangia
Anita
A
Orlando
Claudio
C
Verderio
Paolo
P
Belfiglio
Maurizio
M
Marchetti
Antonio
A
Bertario
Lucio
L
Chiappetta
Gennaro
G
Gion
Massimo
M
Tonini
Gian Paolo
GP
Podo
Franca
F
Vocaturo
Amina
A
Silvestrini
Rosella
R
Romani
Massimo
M
Belloni
Elena
E
Cavallo
Delia
D
Ulivi
Paola
P
Tommasi
Stefania
S
Steffan
Agostino
A
Russo
Antonio
A
Alessio
Massimo
M
Calistri
Daniele
D
Zancan
Matelda
M
Parrela
Paola
P
Broggini
Massimo
M
Giuseppe
Antonio
A
Buttitta
Fiamma
F
Finocchiaro
Gaetano
G
Mazzocco
Katia
K
Veronesi
Giulia
G
Landuzzi
Lorena
L
Benevolo
Maria
M
Mariani
Luciano
L
De Marco
Federico
F
Venuti
Aldo
A
Giannelli
Gianluigi
G
Quaranta
Michele
M
Trojano
Vito
V
D014408:Biomarkers, Tumor / Q000032:analysis*; D005260:Female; D005833:Genital Neoplasms, Female / Q000175:diagnosis; D005834:Genital Neoplasms, Male / Q000175:diagnosis; D006801:Humans; D007558:Italy; D008297:Male; D009369:Neoplasms / Q000175:diagnosis*; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D014408:Biomarkers, Tumor