150 Chapter 7 cancer screening or triage tests could reduce the number of colposcopy referrals and the need for further follow-up testing among both unvaccinated and vaccinated women with regressive cervical lesions. Additionally, these panels have shown improved triage performance in cervical cancer screening compared to hrHPV genotyping, pap cytology or a combination of the two in unvaccinated women 13, 18, 19. Overall, methylation markers have demonstrated good performance among unvaccinated women, but require thorough evaluation among HPV-vaccinated women. A recent study reported surgically treated low-grade squamous intraepithelial (LSIL) and HSIL cervical lesions among HPV-vaccinated women 20. In this study, we aimed to evaluate established methylation markers in cervical LSIL and HSIL lesions among HPV-vaccinated women. MATERIAL AND METHODS STUDY ENROLMENT, FOLLOW-UP, AND SAMPLING A community-randomised, phase IV trial (NCT00534639) comparing the impact of gender-neutral versus girls-only HPV vaccination strategies was conducted in Finnish junior high-schools and municipal study sites. The trial spanned from 2007 to 2010 (vaccination phase) 21, and from 2010 to 2014 for the follow-up phase 22. A total of 80,000 early adolescents, aged 12 to 15 year, born between 1992 and 1995, were invited to participate. Among them 32,175 (20,514 girls and 11,661 boys) attended the trial. Of the girls, 12,402 received three doses of the bivalent HPV16/18 vaccine, while 8,112 girls received the hepatitis B-virus (HBV) control vaccine during the vaccination phase (20072010). During the follow-up phase (2010-2014), 18-year-old female study participants attended the municipal study sites for pelvic examination, during which cervical cytological samples were obtained. At this phase, 2,284 participants who originally received the HBVvaccine were administered three doses of the bivalent HPV16/18 vaccine, as previously described 20, 22. In 2014, all 14,686 HPV16/18 vaccine recipients were individually re-randomised and invited to participate in a trial (NCT02149030) comparing the accuracy of frequent versus infrequent screening of HPV-vaccinated women at ages 22, 25 and 28 3, 20. A total of 6,958 females consented to participate in the screening trial and extended follow-up. Samples for this study were obtained at the third follow-up visit, at age 25, prior to histological confirmation of LSIL or HSIL cervical lesions among HPV-vaccinated women. Pap cytology was collected simultaneously with the cervical sample used for HPV genotyping and DNA
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