RESUMEN
BACKGROUND: A change of cervical cancer screening algorithms to an HPV-based screening setting is discussed in many countries, due to higher sensitivity of HPV testing compared to cytology. Reliable triage methods are, however, an essential prerequisite in such a setting to avoid overtreatment and higher screening costs. RESULTS: In this study, a series of cervical scrapes collected in PreservCyt liquid-based cytology (LBC) medium from women with cervical cancer (n = 5), cervical intraepithelial neoplasia grade 1-3 (n = 74), and normal cytology (n = 201; further n = 352 collected in SureThin®) were assessed for methylation of the marker regions ASTN1, DLX1, ITGA4, RXFP3, SOX17, and ZNF671 using the GynTect assay and compared to cobas® HPV and CINtec Plus® biomarker results. All samples from women with cervical cancer, 61.2% of CIN3, 44.4% of CIN2 and 20.0% of CIN1 cases were scored positive for the GynTect methylation assay. In contrast, all CIN, irrespective of severity grade, and carcinomas were positive by both, CINtec Plus and cobas HPV. The specificity of GynTect for CIN3+ was 94.6% compared to 69.9% for CINtec Plus and 82.6% for cobas HPV (all HPV types) and 90.6% for cobas HPV 16/18. DNA methylation analysis of this methylation marker panel (GynTect assay) in cervical scrapes consistently detects cervical cancer and the majority of CIN3 as well as a subset of CIN1/2 lesions. The detection rate among cytologically normal samples is extraordinarily low (1.5%). CONCLUSION: GynTect shows excellent performance when using cervical scrape material collected in liquid-based cytology media, a prerequisite for employing such a test as a triage in screening programs. Compared to the other test systems used in this work, GynTect showed higher specificity while still detecting all cancer cases.
Asunto(s)
Biomarcadores de Tumor/genética , Metilación de ADN/genética , Detección Precoz del Cáncer/métodos , Lesiones Precancerosas/genética , Neoplasias del Cuello Uterino/genética , Estudios de Cohortes , Técnicas Citológicas/métodos , Femenino , Papillomavirus Humano 16/genética , Humanos , Lesiones Precancerosas/patología , Neoplasias del Cuello Uterino/patologíaRESUMEN
OBJECTIVES: To estimate the efficacy and side effects of Monsel solution for hemostasis after cervical punch biopsy. METHODS: In a prospective, randomized trial, we compared application of Monsel solution versus a "wait and see" approach in women undergoing cervical punch biopsies in a 1:1 ratio. The primary end point was vaginal bleeding (VB) after 15 minutes measured by scoring a sanitary pad with a 5-level pictogram. Secondary end points were VB after 3, 6, and 24 hours (5-level pictogram), subjective estimation of overall VB during 24 hours, pain after 15 minutes and subjective estimation of overall pain after 24 hours, and overall satisfaction after 24 hours (11-level visual analogue scale). RESULTS: One hundred forty-five women were randomized between July 2015 and January 2016. Mean objective VB scores after 15 minutes in 75 women with Monsel solution were 1.2 ± 0.6 compared with 1.8 ± 1.0 in 70 women without Monsel solution (P < 0.001). The secondary end points VB after 3 and 6 hours, but not after 24 hours, were also in favor of Monsel solution (2.1 ± 1.1 vs 2.9 ± 1.2; P < 0.001; 1.6 ± 0.7 vs 2.2 ± 1.0; P < 0.001; 1.6 ± 0.9 vs 1.7 ± 0.9; P = 0.4, respectively). Subjective estimation of overall VB during 24 hours was lower for Monsel solution (23.2 ± 15.8 vs 35.9 ± 19.5; P < 0.001), but pain after 15 minutes, overall pain, and overall satisfaction were not significantly different between groups (19.2 ± 14.4 vs 17.9 ± 16.2; P = 0.3; 20.7 ± 15.8 vs 20.1 ± 18.0; P = 0.5; and 44.1 ± 21.5 vs 43.6 ± 23.2; P = 0.9, respectively). CONCLUSIONS: Application of Monsel solution significantly reduces bleeding for 6 hours after cervical biopsy but does not affect overall pain or overall satisfaction.