Performance of HPV E4 and p16

Cervical intraepithelial neoplasia grade 2 (CIN2) represents a spectrum of lesions with variable progression and regression. Pathological diagnosis of CIN2 is subjective and poorly reproducible. Accurate diagnosis and identification of different patterns of CIN2 related to outcome are essential to reduce the risks of overtreatment or undertreatment. It is important to explore novel methods for risk stratification of CIN2 to enable targeted treatment of women at high risk of progression or persistent disease and follow-up of women at low risk. The combination of the novel biomarker human papillomavirus (HPV) E4 with p16 We will conduct a historical cohort study including 500 women aged 23-40 years with a first CIN2 diagnosis in Aarhus, Denmark during 2000-2010. Women will be eligible if they have undergone active surveillance and have no previous record of hysterectomy, cone biopsy, and CIN2 or worse. Women will be randomly selected through the Danish Pathology Databank. Tissue samples from women included will be sectioned for p16 The study has been approved by the Ethical Committee in Central Denmark Region (1-10-72-60-20) and registered at the Faculty of Health, Aarhus University. Results will be published in a peer-reviewed journal and presented at scientific meetings. NCT05049252.

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Déclaration de conflit d'intérêts

Competing interests: AH has received a speaker’s fee from AstraZeneca, Denmark outside the work of this study. AH and RKD have received reagents at reduced cost from Roche Denmark. MS has received consultant fee from Roche, Merck, BD Life Science, Abbott Molecular, Inovio Pharmaceuticals and a speaker’s fee from Roche and BD Life Science outside the work of this study. DJ has received a consultant fee from DDL Diagnostic Laboratory and support for participation in International Papillomavirus Conference and Eurogin meetings outside the work of this study. MdK has received grants from Viroclinics-DDL outside the work of this study. The remaining authors report no conflicts of interest.