title: The New Technologies for Cervical Cancer Screening randomised controlled trial. An overview of results during the first phase of recruitment.
abstract: OBJECTIVE
  To study the impact of different cervical cancer screening strategies including HPV testing.
  
  
  METHODS
  A randomised controlled trial with a conventional arm (conventional cytology) and an experimental arm following two phases (first HPV testing+conventional cytology, second HPV testing alone). In phase one, different protocols were applied to different age groups (25-34 and 35-60). Published data on test accuracy during the phase one of recruitment are summarised.
  
  
  RESULTS
  45,307 women were recruited in phase one (about 95,000 overall). In the age group 35-60, HPV testing (by Hybrid Capture 2) alone at 2 RLU cut-off increased sensitivity vs. conventional cytology (relative sensitivity 1.41; 95% CI: 0.98-1.02) with a small loss in Positive Predictive Value (PPV; relative PPV 0.75; 95% CI: 0.45-1.25). Adding liquid-based cytology as screening test and referring to colposcopy women positive to either only marginally increased sensitivity but strongly reduced PPV. In the age group 25-34, similar results (relative sensitivity vs. conventional cytology 1.58; 95% CI: 1.032.44; relative PPV 0.78; 95% CI: 0.72-1.16) were obtained, despite 14% of women were HPV positive, with a strategy based on HPV alone as screening test, triaging HPV positive women by cytology, directly referring those ASCUS+ to colposcopy and repeating both tests after 1 year in those with normal cytology.
  
  
  CONCLUSIONS
  HPV testing, if used as screening test, should be applied alone, with cytology triage essential in younger women but preferable at all ages. Follow-up data will allow analysis of the safety of prolonging screening intervals and the relative persistence of lesions detected with different methods.
authors.affiliation: Centro per la Prevenzione Oncologica (CPO), Torino, Italy. guglielmo.ronco@cpo.it
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Ronco
authors.forename: Silvia
authors.initials: S
authors.lastname: Brezzi
authors.forename: Francesca
authors.initials: F
authors.lastname: Carozzi
authors.forename: Paolo
authors.initials: P
authors.lastname: Dalla Palma
authors.forename: Paolo
authors.initials: P
authors.lastname: Giorgi-Rossi
authors.forename: Daria
authors.initials: D
authors.lastname: Minucci
authors.forename: Carlo
authors.initials: C
authors.lastname: Naldoni
authors.forename: Nereo
authors.initials: N
authors.lastname: Segnan
authors.forename: Marco
authors.initials: M
authors.lastname: Zappa
authors.forename: Manuel
authors.initials: M
authors.lastname: Zorzi
authors.forename: Jack
authors.initials: J
authors.lastname: Cuzick
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000517:prevention & control / Q000821:virology; D014626:Vaginal Smears