Introduction/Background High-risk human papillomavirus (hrHPV) testing to triage women with abnormal cervical lesions (cancer) generates many referrals. hrHPV infection and excessive colposcopy referrals may lead to panic in patient and bring waste of medical resources.
Methodology From 2019 to 2022, a prospective study of outpatient opportunistic cervical cancer screening was conducted with multiple centers. More than 20,000 subjects were collected and be follow-up for one year. The research team of Peking Union Medical College Hospital is responsible for preliminary experiment, clinical study planning, and process quality control. The analysis of methylation level was determined by using the CisCer methylation real-time system (CISPOLY Co., China). Positive rate, sensitivity, specificity, accuracy for cytology, hrHPV, and the methylation level of PAX1 and JAM3 genes were analyzed.
Results A system set-up study in 2210 hrHPV infection subjects including normal uterine cervix (n=1230), CIN1(n=514), CIN2(n=69), CIN3/CIS(n=194), SCC (n=50), and adenocarcinoma (n=6) of the uterine cervix diagnosed according to histological results. The CIN2, CIN3, and Cancer immediate risk with HPV 16/18 (n=810) and non-16/18 hrHPV (n=1400) were 33.83%, 20.99%, 6.17% and13.71%, 5.71%, 0.43% respectively. The sensitivity and specificity of CisCer methylation were 67.2% and 89.6% in all CIN3+ subjects compared with HPV16/18 (68% and 66.4%) and LBC (≥ASCUS; 93.6% and 23.6%). The specificity of HPV 16/18 and CisCer methylation combined screening method were 96.1% in CIN3+. The CIN2, CIN3, and cancer immediate risk with combined screening method were 79.2%, 61.46%, and 26.04%, respectively.
Conclusion The preliminary results indicated that the CisCer testing is promised for cervical cancer detection with high sensitivity and specificity for hrHPV. It can be used as a new non-invasive diagnosis method and its utility as a second triage step after hrHPV testing in women with cervical lesions to improve the accuracy of referral colposcopy.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.