Multi-center clinical study using optical coherence tomography for evaluation of cervical lesions in-vivo
Objective:To evaluate the clinical value of optical coherence tomography(OCT)in the early diagnosis of cervical lesions.Methods:From February to November 2023,1295 women who visited the colposcopy in the gynecological outpatient department of 5 tertiary hospitals in Hubei Province were included in the study.OCT was performed before colposcopy,bi-opsy and/or endocervical curettage was then performed.To evaluate the diagnostic performance of OCT alone or in combination with HPV detection for cervical intraepithelial neoplasia(CIN)grade 2 and worse(CIN2+)/CIN3 and worse(CIN3+)with histological diagnosis as the gold standard.Results:122 women were diagnosed as CIN2,131 women were diagnosed as CIN3+le-sions.The specificity and accuracy of OCT in the diagnosis of CIN2+/CIN3+were 93.9％/88.2％,89.5％/87.6％,respectively,which were significantly higher than those of HPV and TCT(P＜0.001).The sensitivity of OCT diagnosis was lower than that of HPV detection(71.5％vs 95.7％,82.4％vs 95.4％,P＜0.001).The sensitivity of OCT combined with HPV test and TCT combined with HPV test was similar,but the specificity,accuracy,PPV and NPV were all higher than that of TCT combined with HPV test,and the difference was statistically significant(P＜0.05).For patients with hr HPV infection,the referral rate of colposcopy based on OCT triage was much lower than that based on TCT(non-16/18 hr HPV:14.6％vs 72.1％,hr HPV:20.9％vs 61.3％,P＜0.001).For patients with non-16/18 hr HPV infection,the risk of CIN3+in OCT-negative patients with TCT abnormalities was 2.1％(＜4％),and the risk of CIN3+in OCT-posi-tive patients with normal TCT was 38.5％.Conclusion:OCT testing alone or in combination with HPV testing has good diagnostic performance for early screening of cervical CIN2/CIN3+,and OCT triage can reduce the rate of colposcopy referral in patients with hr HPV infection.
Cervical cancer screeningMulticenterOptical coherence tomographyHPVTCTAccuracy
万方数据
维普
