Study population
Participants were women who visited gynecology clinics in four hospitals
for routine cervical cancer or precancer screening between December 2017
and November 2018, aged from 27 to 70 years. The protocol, inclusion and
exclusion criteria of the study are shown in Figure 1 .
At the first visiting for gynecological examination in multi-center
clinics, cervical samples were obtained to conduct the HPV detection,
cytology and S5 methylation analyses. Women with HPV-positive results
and/or abnormal cytology results (HPV positive and/or cytology with
ASCUS, LSIL, ASC-H, HSIL or CC) at the first visiting time were
recruited in the study. All the included participants were divided into
two groups, women with HPV16/18+ and/or ≥ (TCT)HSIL result of cytology
at first visiting time were divided into receive immediate colposcopy
group (IC group; n=602), women with (“HPV positive except HPV16/18”
and “abnormal cytology results except ≥ (TCT)HSIL”) were divided into
repeat follow-up group (RF group; n=1644) including scheduled cytology
and HPV tests every 6 months for 2 years follow-up period (which means
scheduled study visit at 6, 12, 18 and 24 months). Colposcopy and
biopsies were performed if women were divided into the IC group, also
colposcopy and biopsies were performed if either repeated ≥LSIL or
repeated hrHPV+ was observed during the 24-month follow-up period in the
RF group. All the histological samples and cytology samples were reviewd
by a standardized group of pathologists, all the pathologists and
cytopathologists were blinded to the HPV infection status.