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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University Hospital for Infectious Diseases, Croatia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University Hospital for Infectious Diseases, Croatia
ClinicalTrials.gov Identifier:
NCT01385436
First received: June 24, 2011
Last updated: June 29, 2011
Last verified: June 2011

June 24, 2011
June 29, 2011
May 2010
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01385436 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia
Pre-vaccination Distribution of Human Papillomavirus (HPV) Genotypes in Patients With High Grade Cervical Squamous Intraepithelial Lesion (HSIL) and Cervical Cancer From Croatia

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

DNA isolates from biopsy specimens of cervical lesions.

Probability Sample

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.

Cervical Cancer
Not Provided
HPV HSIL cervical carcinoma

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact: Adriana Vince, MD, PhD ++38512826222 avince@bfm.hr
Croatia
 
NCT01385436
UHID-02
No
Prof Adriana Vince, MD, PhD, University Hospital for Infectious Diseases, Croatia
University Hospital for Infectious Diseases, Croatia
Merck Sharp & Dohme Corp.
Principal Investigator: Adriana Vince, MD, PhD University Hospital for Infectious Diseases Zagreb, Croatia
University Hospital for Infectious Diseases, Croatia
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP