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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV HSIL cervical carcinoma |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HPV vaccine coverage in Croatia | To evaluate the percentage of HSIL and cervical cancer that can be prevented by current HPV vaccine. | two years |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 18-65 with a cytological diagnosis of CIN2+cervical lesions from all over Croatia that are referred to the National Reference Center because of HSIL or malignant cytology findings.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adriana Vince, MD, PhD | Contact | ++38512826222 | avince@bfm.hr |
| Name | Affiliation | Role |
|---|---|---|
| Adriana Vince, MD, PhD | University Hospital for Infectious Diseases Zagreb, Croatia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital for Infectious Diseases, Croatia | Recruiting | Zagreb | 10 000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18752054 | Background | 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. | |
| 17702646 |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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DNA isolates from biopsy specimens of cervical lesions.
| 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. doi: 10.1016/j.jcv.2007.07.002. Epub 2007 Aug 16. No abstract available. |
| 19683958 | Background | 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. |
| 21114573 | Background | 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. |
| 20954880 | Background | 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. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |