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

NCT01385436 | Unknown

• 1 other identifier: UHID-02
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

human papillomavirus (HPV); cervical cancer; high grade cervical squamous intraepithelial lesion (HSIL)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• HPV vaccine coverage in Croatia

  two years

Study Arms (1)

HPV HSIL cervical carcinoma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Women younger than 18 or older than 65
• Pregnant women

Sponsors & Collaborators

• University Hospital for Infectious Diseases, Croatia: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University Hospital for Infectious Diseases, Croatia

Zagreb, 10 000, Croatia

RECRUITING

Related Publications (5)

• 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.

  PMID: 18752054 BACKGROUND

• 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.

  PMID: 17702646 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.

  PMID: 19683958 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.

  PMID: 21114573 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.

  PMID: 20954880 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA isolates from biopsy specimens of cervical lesions.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Adriana Vince, MD, PhD

  University Hospital for Infectious Diseases Zagreb, Croatia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Vince, MD, PhD

CONTACT

++38512826222; avince@bfm.hr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 30, 2011
• Study Start: May 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: June 30, 2011

Record last verified: 2011-06

Locations

CR (1)