title: Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial -- the HPV FOCAL Study.
abstract: BACKGROUND
  Round 1 data of human papillomavirus (HPV) FOCAL, a three-arm, randomised trial, which aims to establish the efficacy of HPV DNA testing as a primary screen for cervical cancer, are presented.
  
  
  METHODS
  The three arms are: Control arm - liquid based cytology with atypical squamous cells of unknown significance (ASC-US) triage with hrHPV testing; Intervention Arm - hrHPV at entry with liquid-based cytology (LBC) triage of hrHPV positives, with exit screen at 4 years; Safety check arm - hrHPV at entry with LBC triage of hrHPV positives with exit screen at 2 years.
  
  
  RESULTS
  A total of 6154 women were randomised to the control arm and 12 494 to the HPV arms (intervention and safety check). In the HPV arm, the baseline cervical intraepithelial neoplasia (CIN)2+ and CIN3+ rate was 9.2/1000 (95%CI; 7.4, 10.9) and 4.8/1000 (95%CI; 3.6, 6.1), which increased to 16.1/1000 (95%CI 13.2, 18.9) for CIN2+ and to 8.0/1000 (95%CI; 5.9, 10.0) for CIN3+ after subsequent screening of HPV-DNA-positive/cytology-negative women. Detection rate in the control arm remained unchanged after subsequent screening of ASC-US-positive/hrHPV DNA-negative women at 11.0/1000 for CIN2+ and 5.0/1000 for CIN3+.
  
  
  CONCLUSIONS
  After subsequent screening of women who were either hrHPV positive/cytology negative or ASC-US positive/HPV negative, women randomised to the HPV arms had increased CIN2+ detection compared with women randomised to the cytology arm.
authors.affiliation: Department of Family Practice, University of British Columbia, Vancouver V5Z 4R4, British Columbia, Canada. gina.ogilvie@bccdc.ca
authors.forename: G S
authors.initials: GS
authors.lastname: Ogilvie
authors.forename: M
authors.initials: M
authors.lastname: Krajden
authors.forename: D J
authors.initials: DJ
authors.lastname: van Niekerk
authors.forename: R E
authors.initials: RE
authors.lastname: Martin
authors.forename: T G
authors.initials: TG
authors.lastname: Ehlen
authors.forename: K
authors.initials: K
authors.lastname: Ceballos
authors.forename: L W
authors.initials: LW
authors.lastname: Smith
authors.forename: L
authors.initials: L
authors.lastname: Kan
authors.forename: D A
authors.initials: DA
authors.lastname: Cook
authors.forename: S
authors.initials: S
authors.lastname: Peacock
authors.forename: G C E
authors.initials: GC
authors.lastname: Stuart
authors.forename: E L
authors.initials: EL
authors.lastname: Franco
authors.forename: A J
authors.initials: AJ
authors.lastname: Coldman
mesh_terms: D000328:Adult; D000465:Algorithms; D052685:Alphapapillomavirus / Q000235:genetics / Q000302:isolation & purification*; D002170:Canada / Q000453:epidemiology; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000821:virology; D003127:Colposcopy; D003584:Cytological Techniques / Q000379:methods*; D004279:DNA, Viral / Q000302:isolation & purification; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000150:complications* / Q000175:diagnosis* / Q000453:epidemiology; D012747:Sexual Partners; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000517:prevention & control / Q000821:virology*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000821:virology
chemical_list: D004279:DNA, Viral