Trial Information

Pre-vaccination Distribution of Human Papillomavirus (HPV) Genotypes in Patients With High Grade Cervical Squamous Intraepithelial Lesion (HSIL) and Cervical Cancer From Croatia

This is a single-center cross-sectional study on the molecular virology of human
papillomavirus (HPV) in Croatia. The study will enroll women aged 18-65 years of age with
cervical intraepithelial neoplasia (CIN2+)cervical lesions that received clinical care at
the Croatian Center for Pre-malignant and Malignant Diseases of the Cervix. Women with
abnormal cytology (high grade cervical squamous intraepithelial lesion-HSIL, cervical
cancer) in the period from 2010 to 2012 will be included. Relevant epidemiological and
clinical data will be collected. Biological samples will include both biopsy specimens from
cervix and cervical swab. Biological samples will be put in Digene Specimen Transport Medium
(Qiagen, Gaithersburg, MD) and further analyzed at the Department of Molecular Diagnostics
at the University Hospital for Infectious Diseases in Zagreb. HPV genotyping will be
performed by using a standardized molecular assay INNO-LiPA HPV Genotyping Extra Test
(Solvay S.A., Brussels, Belgium). Analysis of genomic variants of HPV 16 genotype will be
performed by population-based sequencing of L1 genome region.