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.
National Cancer Institute Giovanni Paolo II, Bari, Italy. a.paradiso@oncologico.bari.it
Angelo
A
Paradiso
Anita
A
Mangia
Claudio
C
Orlando
Paolo
P
Verderio
Maurizio
M
Belfiglio
Antonio
A
Marchetti
Lucio
L
Bertario
Gennaro
G
Chiappetta
Massimo
M
Gion
Gian Paolo
GP
Tonini
Franca
F
Podo
Amina
A
Vocaturo
Rosella
R
Silvestrini
Massimo
M
Romani
Elena
E
Belloni
Delia
D
Cavallo
Paola
P
Ulivi
Stefania
S
Tommasi
Agostino
A
Steffan
Antonio
A
Russo
Massimo
M
Alessio
Daniele
D
Calistri
Matelda
M
Zancan
Paola
P
Parrela
Massimo
M
Broggini
Antonio
A
Giuseppe
Fiamma
F
Buttitta
Gaetano
G
Finocchiaro
Katia
K
Mazzocco
Giulia
G
Veronesi
Lorena
L
Landuzzi
Maria
M
Benevolo
Luciano
L
Mariani
Federico
F
De Marco
Aldo
A
Venuti
Gianluigi
G
Giannelli
Michele
M
Quaranta
Vito
V
Trojano
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