Background DNA methylation is an essential factor in the progression of cervical intraepithelial neoplasia (CIN) to cervical cancer. The aim was to investigate the diagnostic value provided by methylation biomarkers of six tumor suppressor genes (ASTN1, DLX1, ITGA4, RXFP3, SOX17 and ZNF671) for cervical precancerous lesions and cervical cancer. Methods The histological cervical specimens of 396 cases including 93 CIN1, 99 CIN2, 93 CIN3 and 111 cervical cancers were tested for methylation-specific PCR assay (GynTect®) of score and positive rate. Among them, 66 CIN1, 93 CIN2, 87 CIN3 and 72 cervical cancers were further used for paired analysis. A chi-square test was used to analyze the difference of methylation score and positive rate in cervical specimens. The paired t-test and paired chi-square test were for analyzing the methylation score and positive rate in paired CIN and cervical cancer cases. The specificity, sensitivity, odds ratio (OR) and 95% confidence interval (95% CI) of the GynTect® assay for CIN2 or worse (CIN2 +) and CIN3 or worse (CIN3 +) were evaluated. Results According to the chi-square test trend, hypermethylation increased with severity of the lesions as defined by histological grading (P = 0.000). The methylation score above 1.1 was more common in CIN2 + than in CIN1. The DNA methylation scores in the paired groups of CIN1, CIN3 and cervical cancer were significant differences (P = 0.033, 0.000 and 0.000, respectively), except for CIN2 (P = 0.171). While the positive rate of GynTect® in each paired group had no difference (all P > 0.05). The positive rate of every methylation marker in the GynTect® assay showed differences in four cervical lesion groups (all P < 0.05). The specificity of GynTect® assay for detection of CIN2 + /CIN3 + were higher than high-risk human papillomavirus test. With CIN1 as a reference, the positive status of GynTect®/ZNF671 were significantly higher in CIN2 + : odds ratio (OR) 5.271/OR 13.909, and in CIN3 + : OR 11.022/OR 39.150, (all P < 0.001). Conclusion The promoter methylation of six tumor suppressor genes is related to the severity of cervical lesions. The GynTect® assay based on cervical specimens provides diagnostic values for detecting CIN2 + and CIN3 + .
Objective This study aimed to evaluate the feasibility of combined human papillomavirus (HPV) and optical coherence tomography (OCT) cervical cancer screening strategies. Materials and Methods The OCT and cytology results were compared with the pathological results to calculate the sensitivity, specificity, positive predictive value, negative predictive value, and immediate cervical intraepithelial neoplasia grade 3 or worse (CIN3+) risk. The authors compared the efficiency of colposcopy by using different triage strategies. They discussed differentiation in OCT screening in different age groups. Results Eight hundred thirteen participants with high-risk HPV-positive and cervical cytology results underwent OCT before colposcopy between March 1 and October 1, 2021. The HPV16/18 genotyping with OCT triage has a specificity of CIN3+ lesions (61.1%; 95% CI = 57.6%–64.6%), intraepithelial neoplasia grade 2 or worse (CIN2+) (66.0%; 95% CI = 62.4%–69.6%). The HPV16/18 genotyping with cytology triage has a specificity of CIN3+ (44.0%; 95% CI = 40.4%–47.6%), CIN2+ (47.0%; 95% CI = 43.2%–50.8%). The OCT triage has a higher positive predictive value compared with the cytology, with a significant difference in CIN2+ lesions (45.0%; 95% CI = 38.8%–51.3% vs 29.2%; 95% CI = 24.7%–33.7%). Conclusions The combination of OCT and high-risk HPV triage (both genotyping and nongenotyping) had a similar immediate CIN3+ risk stratification and reduced the number of colposcopies compared with the cytological triage strategy.
Objective To assess triage of HPV-positive women by optical coherence tomography (OCT), with or without HPV16/18 genotyping, compare with cytology. Design A prospective cohort study. Setting The Second Xiangya Hospital in China. Population 813 participants with high-risk HPV(hrHPV)-positive and cervical cytology results received OCT before colposcopy between 1 March 2021 and 1 October 2021. Methods OCT examinations were performed on an outpatient basis. Cytological and histological results during follow-up were obtained from the Department of Pathology at the Second Xiangya Hospital. Main outcome measures OCT and cytology results were compared with the pathological results to calculate sensitivity, specificity, and immediate CIN3+ risk. The advantages and disadvantages of OCT and cytology triage of hr-HPV-positive women were compared. Results HPV16/18 genotyping with OCT triage has a specificity of CIN3+ lesions [61.1%; 95% CI, 57.6%-64.6%], CIN2+ [66.0%; 95% CI, 62.4%-69.6%]. HPV16/18 genotyping with cytology triage has a specificity of CIN3+[44.0%; 95% CI, 40.4%-47.6%], CIN2+ [47.0%; 95% CI, 43.2%-50.8%]. The OCT triage has a higher specificity and positive predictive value(PPV) compared to the cytology with a significant difference. The OCT triage has a similar immediate CIN3+ risk compared to the cytology. Conclusion The combination of OCT and HPV triage (both genotyping and non-genotyping) is feasible in terms of immediate CIN2+/CIN3+ risk, and the OCT triage strategy reduces the number of colposcopies and improves the specificity and positive predictive value of the test compared to the cytological triage strategy.
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