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Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia — HPV-cancer  

Cervical Cancer Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01385436
Study type Observational
Source University Hospital for Infectious Diseases, Croatia
Contact Adriana Vince, MD, PhD
Phone ++38512826222
Email avince@bfm.hr
Status Recruiting
Phase N/A
Start date May 2010
Completion date December 2013
View Details
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