title: Molecular profile in body fluids in subjects enrolled in a randomised trial for lung cancer screening: Perspectives of integrated strategies for early diagnosis.
abstract: The aim of this study was to evaluate the diagnostic value of a grid of molecular genetic markers detectable in sputum and plasma samples of individuals enrolled in a lung cancer screening program with low-dose CT. Subjects enrolled in the baseline screening round of the ITALUNG (randomised) screening trial were invited to provide biological specimens for molecular analysis (1356 subjects out of 1406). We included 98 subjects in this analysis. There was a highly statistically significant difference between proportion of subjects with a negative baseline CT screening test who were positive to allelic imbalance, and those with a non-calcified nodule (NCN greater than or equal to 5mm), the reason of recall for all suspects at CT Scan (chi(2): 22.9; P<0.0001). Allelic imbalance showed good performance for screening of NCN > or = 5 mm. In subjects recalled for NCN > or = 5 mm, LOH, K-ras mutations and high levels of free plasma DNA (>5ng/ml plasma) might be important to support clinical decision making for further follow-up and repeated screening. This study, embedded in an early diagnosis randomised trial, suggests that a multi-screening approach integrating imaging technique and a biomolecular marker panel is worth of further investigation.
authors: Analytical and Biomolecular Cytology Unit, ISPO Cancer Prevention and Research Institute, Via Cosimo Il Vecchio 2, 50139 Florence, Italy. f.carozzi@ispo.toscana.it
authors: Francesca Maria
authors: FM
authors: Carozzi
authors: Simonetta
authors: S
authors: Bisanzi
authors: Patrizia
authors: P
authors: Falini
authors: Cristina
authors: C
authors: Sani
authors: Giulia
authors: G
authors: Venturini
authors: Andrea
authors: A
authors: Lopes Pegna
authors: Roberto
authors: R
authors: Bianchi
authors: Cristina
authors: C
authors: Ronchi
authors: Giulia
authors: G
authors: Picozzi
authors: Mario
authors: M
authors: Mascalchi
authors: Laura
authors: L
authors: Carrozzi
authors: Filomena
authors: F
authors: Baliva
authors: Francesco
authors: F
authors: Pistelli
authors: Laura
authors: L
authors: Tavanti
authors: Fabio
authors: F
authors: Falaschi
authors: Michela
authors: M
authors: Grazzini
authors: Florio
authors: F
authors: Innocenti
authors: Eugenio
authors: E
authors: Paci
mesh_terms: D000368:Aged; D022981:Allelic Imbalance / Q000235:genetics; D004247:DNA / Q000032:analysis / Q000097:blood*; D004252:DNA Mutational Analysis; D055088:Early Detection of Cancer; D005500:Follow-Up Studies; D011905:Genes, ras / Q000235:genetics; D005820:Genetic Testing; D006801:Humans; D008175:Lung Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000235:genetics / Q000473:pathology / Q000503:physiopathology; D018895:Microsatellite Repeats / Q000235:genetics; D008875:Middle Aged; D011379:Prognosis; D003074:Solitary Pulmonary Nodule / Q000097:blood / Q000175:diagnosis* / Q000235:genetics / Q000473:pathology / Q000503:physiopathology; D013183:Sputum / Q000737:chemistry*
chemical_list: D004247:DNA