Faecal immunochemical test in subjects not attending screening computed tomography colonography and colonoscopy in a randomized trial Lapo Sali a , Leonardo Ventura b , Mario Mascalchi a , Massimo Falchini a , Paola Mantellini b , Silvia Delsanto c , Stefano Milani a , Marco Zappa b and Grazia Grazzini b The aim of this study was to evaluate the participation and yield of the faecal immunochemical test (FIT) in nonattendees for computed tomography colonography (CTC) or optical colonoscopy (OC) screening, in the setting of a randomized trial. In the SAVE trial, 16087 individuals were randomly assigned and invited to one of four interventions for colorectal cancer screening: (i) biennial FIT for three rounds; (ii) reduced-preparation CTC; (iii) full- preparation CTC; and (iv) OC. Nonattendees of reduced- preparation CTC, full-preparation CTC and OC groups were invited to FIT. Here, we analysed the participation rate and the detection rate for cancer or advanced adenoma (advanced neoplasia) of FIT among nonattendees for reduced-preparation CTC, full-preparation CTC and OC. Nonattendees were 1721 of 2395 (71.9%) eligible invitees in the reduced-preparation CTC group, 1818 of 2430 (74.8%) in the full-preparation CTC group and 883 of 1036 (85.2%) in the OC group. Participation rates for FIT were 20.2% (347/1721) in nonattendees for reduced-preparation CTC, 21.4% (389/1818) in nonattendees for full-preparation CTC and 25.8% (228/883) in nonattendees for OC. Differences between both CTC groups and the OC group were statistically significant (P ≤ 0.01), whereas the difference between reduced-preparation and full-preparation CTC groups was not statistically significant (P = 0.38). The detection rate of FIT was not statistically significantly different among nonattendees for reduced-preparation CTC (0.9%; 3/347), nonattendees for full-preparation CTC (1.8%; 7/389) and nonattendees for OC (1.3%; 3/228) (P > 0.05). Offering FIT to nonattendees for CTC or OC increases the overall participation in colorectal cancer screening and enables the detection of additional advanced neoplasia. European Journal of Cancer Prevention 00:000–000 Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. European Journal of Cancer Prevention 2016, 00:000–000 Keywords: colonoscopy, colorectal cancer screening, computed tomography colonography, faecal immunochemical test, faecal occult blood test a Department of Biomedical, Experimental and Clinical Sciences ‘Mario Serio’ , University of Florence, b Cancer Prevention and Research Institute (ISPO), Screening Unit, Florence and c Im3D S.p.A., Turin, Italy Correspondence to Lapo Sali, MD, PhD, Department of Biomedical, Experimental and Clinical Sciences ‘Mario Serio’ , University of Florence, Viale Morgagni 50, Florence 50134, Italy Tel: + 39 055 4598201; fax: + 39 055 4598900; e-mail: lapo.sali@unifi.it Received 23 March 2016 Accepted 29 June 2016 Introduction Screening programmes for colorectal cancer (CRC) are implemented in many European countries (Karsa et al., 2008; Zavoral et al., 2009; Schreuders et al., 2015). They are based on the faecal occult blood test (FOBT) or endo- scopic tests, namely flexible sigmoidoscopy (FS) and optical colonoscopy (OC). FOBT decreases CRC mortal- ity (Hewitson et al., 2007), FS is associated with reduction in CRC incidence and OC enables removal of pre- cancerous lesions (Winawer et al., 1993; Atkin et al., 2010; Segnan et al., 2011). FS and OC typically have a higher diagnostic yield, but a lower participation rate than FOBT (Hol et al., 2010; Lisi et al., 2010; Hassan et al., 2012; Stoop et al., 2012; Zorzi et al., 2012; Sali et al., 2015). Recently, computed tomography colonography (CTC) has emerged as a potential screening test for CRC (Levin et al., 2008; Stoop et al., 2012; Sali et al., 2015). Randomized trials have shown that participation in CTC screening is higher than that in OC screening (Stoop et al., 2012; Sali et al., 2015), but lower than that in the faecal immunochemical test (FIT) (Sali et al., 2015). Offering FIT to nonattendees for FS screening has been proposed as a strategy to increase overall participation in CRC screening (Hol et al., 2012; Senore et al., 2013). The SAVE study is a randomized trial investigating four primary screening tests for CRC, namely reduced- preparation and full-preparation CTC, FIT and OC. The main outcomes of the trial at the first screening round were reported previously (Sali et al., 2015). In the present report, we evaluated the participation and detection rate (DR) of FIT in subjects not attending CTC and OC as primary screening tests in the SAVE study. Participants and methods Study design and population The SAVE study is an ongoing single-centre, randomized-controlled trial (Sali et al., 2013). In a district Research paper 1 0959-8278 Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/CEJ.0000000000000284 Copyright r 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.