To assess the performance of HPV-based cervical cancer screening in underserved women in Greece using the cobas® HPV Test on self-collected cervicovaginal samples, in comparison to historical real-life results of cytology-based screening. Secondary objective is to assess the acceptability of the Roche® self-collection device for cervicovaginal specimens.
Women 25-60 years old who do or do not attend cervical cancer screening and reside in rural areas of Greece are being recruited for the study. Approximately 12,700 women will be enrolled over 30 months starting May 2016. Women are contacted by midwifes, forming a nationwide midwifery network set for the study purposes, via public announcement at their place of residence, and are provided, after giving their written informed consent, with a self-sampling kit (Roche®) (cotton swab and dry vial) along with the necessary instructions. Each woman collects the specimen and fills in a questionnaire specifically designed to assess cervical cancer screening participation and outcome history during the last 10 years, and the acceptance of the self-sampling procedure. Samples are tested using the cobas® HPV Test, Roche®, which detects HPVs 16 and 18 separately, and HPVs 31,33,35,39,45,51,52,56,58,59,66 and 68 [other high-risk (OHR)] as a pooled result. Women found positive for HPV are being referred for colposcopy. In case of abnormal colposcopic impression a biopsy is taken. If the histology report is within normal limits the woman is referred to routine screening, if there is Cervical Intraepithelial Neoplasia (CIN) grade 1 or 2 or worse (CIN2+) she is referred to follow up or appropriate treatment respectively.
Between May 2016 and March 2017 6,818 samples were collected, 6,156 were tested, of which 433 (7.0%) were HPV positive, 228 colposcopies were performed and CIN grade 1, 2 and 3 was detected in 17, 12, and 10 cases respectively. HPV16 positive cases were found in 14.2% and 63.6% among the low-grade (CIN1) and high-grade (CIN2+) lesions respectively. Moreover there had been a case of vaginal intraepithelial neoplasia (VaIN – OHR positive) and a case of cervical adenocarcinoma (HPV16 positive). The prevalence of high-grade disease or cancer among HPV positive women examined was 10.5% and among tested women overall 0.4%, about half than expected, since only about half of the HPV positive women have been examined colposcopically so far.
The preliminary report of the GRECOSELF study shows that HPV testing with individual HPV 16/18 genotyping on self-collected cervicovaginal samples is a feasible and effective cervical cancer prevention method for Greek women residing in rural distant areas.