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

Cervical Cancer Clinical Trial

— HPV-cancer  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT01385436
• Other study ID #: UHID-02
• Status: Recruiting
• Phase: N/A
• First received: June 24, 2011
• Last updated: June 29, 2011
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: June 2011
• Source: University Hospital for Infectious Diseases, Croatia
• Contact: Adriana Vince, MD, PhD
• Phone: ++38512826222
• Email: avince[@]bfm.hr
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social Care
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Croatia	University Hospital for Infectious Diseases, Croatia	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital for Infectious Diseases, Croatia	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Croatia, 

References & Publications (5)

Lepej SZ, Grgic I, Poljak M, Iscic-Bes J, Skerk V, Vince DB, Dusek D, Vince A. Detection of human papillomavirus genotypes 16/18/45 by hybrid capture hybridisation genotyping probe in clinical specimens: the first report. J Clin Virol. 2007 Oct;40(2):171-2. Epub 2007 Aug 16. — View Citation

Milutin Gasperov N, Sabol I, Matovina M, Spaventi S, Grce M. Detection and typing of human papillomaviruses combining different methods: polymerase chain reaction, restriction fragment length polymorphism, line probe assay and sequencing. Pathol Oncol Res. 2008 Dec;14(4):355-63. doi: 10.1007/s12253-008-9084-2. Epub 2008 Aug 28. — View Citation

Poljak M, Kocjan BJ. Commercially available assays for multiplex detection of alpha human papillomaviruses. Expert Rev Anti Infect Ther. 2010 Oct;8(10):1139-62. doi: 10.1586/eri.10.104. Review. — View Citation

Seme K, Lepej SZ, Lunar MM, Iscic-Bes J, Planinic A, Kocjan BJ, Vince A, Poljak M. Digene HPV Genotyping RH Test RUO: comparative evaluation with INNO-LiPA HPV Genotyping Extra Test for detection of 18 high-risk and probable high-risk human papillomavirus genotypes. J Clin Virol. 2009 Oct;46(2):176-9. doi: 10.1016/j.jcv.2009.07.017. Epub 2009 Aug 15. — View Citation

Vrtacnik Bokal E, Kocjan BJ, Poljak M, Bogovac Z, Jancar N. Genomic variants of human papillomavirus genotypes 16, 18, and 33 in women with cervical cancer in Slovenia. J Obstet Gynaecol Res. 2010 Dec;36(6):1204-13. doi: 10.1111/j.1447-0756.2010.01316.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-vaccination distribution of HPV genotypes in women with HSIL and invasive cervical carcinoma	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.	two years	No
Secondary	HPV vaccine coverage in Croatia	To evaluate the percentage of HSIL and cervical cancer that can be prevented by current HPV vaccine.	two years	No