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
  Purpose

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.


Condition
Cervical Cancer

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University Hospital for Infectious Diseases, Croatia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 400
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)
Groups/Cohorts
HPV HSIL cervical carcinoma

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385436

Contacts
Contact: Adriana Vince, MD, PhD ++38512826222 avince@bfm.hr

Locations
Croatia
University Hospital for Infectious Diseases, Croatia Recruiting
Zagreb, Croatia, 10 000
Contact: Adriana Vince, MD, PhD    ++38512826222    avince@bfm.hr   
Principal Investigator: Adriana Vince, MD,PhD         
Sub-Investigator: Magdalena Karadža, MD         
Sub-Investigator: Snjezana Zidovec Lepej, MD, PhD         
Sponsors and Collaborators
University Hospital for Infectious Diseases, Croatia
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Adriana Vince, MD, PhD University Hospital for Infectious Diseases Zagreb, Croatia
  More Information

Publications:
Responsible Party: Prof Adriana Vince, MD, PhD, University Hospital for Infectious Diseases, Croatia
ClinicalTrials.gov Identifier: NCT01385436     History of Changes
Other Study ID Numbers: UHID-02
Study First Received: June 24, 2011
Last Updated: June 29, 2011
Health Authority: Croatia: Ministry of Health and Social Care

Keywords provided by University Hospital for Infectious Diseases, Croatia:
human papillomavirus (HPV)
cervical cancer
high grade cervical squamous intraepithelial lesion (HSIL)

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Precancerous Conditions

ClinicalTrials.gov processed this record on July 24, 2014