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

• Conditions: Cervical Cancer

• Registration Number: NCT01385436
• Lead Sponsor: University Hospital for Infectious Diseases, Croatia

Brief 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.

Detailed 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 Timeline

• Study Start: 2010-05
• Status Verified: 2011-06
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-29
• Last Update Submitted: 2011-06-29
• Study First Posted: 2011-06-30
• Last Update Posted: 2011-06-30
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pre-vaccination distribution of HPV genotypes in women with HSIL and invasive cervical carcinoma	two years	To assess the distribution of different high-risk HPV genotypes in biopsy specimens of 400 women with cytological diagnosis of HSIL and cervical cancer. Biopsy will be performed during colposcopy as a part of of routine clinical work-up in women with abnormal PAP smear finding.

Secondary Outcome Measures

Name	Time	Method
HPV vaccine coverage in Croatia	two years	To evaluate the percentage of HSIL and cervical cancer that can be prevented by current HPV vaccine.

Trial Locations

Locations (1)

University Hospital for Infectious Diseases, Croatia; 🇭🇷 Zagreb, Croatia