Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia (HPV-cancer)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|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|
- Pre-vaccination distribution of HPV genotypes in women with HSIL and invasive cervical carcinoma [ Time Frame: two years ] [ Designated as safety issue: No ]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.
- HPV vaccine coverage in Croatia [ Time Frame: two years ] [ Designated as safety issue: No ]To evaluate the percentage of HSIL and cervical cancer that can be prevented by current HPV vaccine.
Biospecimen Retention: Samples With DNA
DNA isolates from biopsy specimens of cervical lesions.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|HPV HSIL cervical carcinoma|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385436
|Contact: Adriana Vince, MD, PhDfirstname.lastname@example.org|
|University Hospital for Infectious Diseases, Croatia||Recruiting|
|Zagreb, Croatia, 10 000|
|Contact: Adriana Vince, MD, PhD ++38512826222 email@example.com|
|Principal Investigator: Adriana Vince, MD,PhD|
|Sub-Investigator: Magdalena Karadža, MD|
|Sub-Investigator: Snjezana Zidovec Lepej, MD, PhD|
|Principal Investigator:||Adriana Vince, MD, PhD||University Hospital for Infectious Diseases Zagreb, Croatia|