Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia
Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia
Human papillomavirus (HPV) of high-risk genotype is a necessary risk factor in development of
 cervical cancer. There is a vaccine available to prevent cervical lesions associated with
 high-risk HPV genotypes 16 and 18. In Croatia HPV vaccination has not yet been introduced in
 obligatory vaccination schedule. The aim of this study is to describe the pre-vaccination
 distribution of HPV genotypes in women with high grade cervical squamous intraepithelial
 lesion (HSIL) and cervical cancer in Croatia. The investigators hypothesis is that HPV-16 is
 the most frequently found genotype but the distribution of other HPV genotypes is
 heterogeneous and includes genotypes currently not covered by vaccination.
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.
Inclusion Criteria:

 -  Women aged 18-65 with a cytological diagnosis of CIN2+cervical lesions from all over
 Croatia that are referred to National Reference Center because of HSIL or malignant
 cytology findings

 Exclusion Criteria:

 -  Women younger than 18 or older than 65

 -  Pregnant women