Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia (HPV-cancer)
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| First Received Date ICMJE | June 24, 2011 | ||||
| Last Updated Date | June 29, 2011 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01385436 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia | ||||
| Official Title ICMJE | Pre-vaccination Distribution of Human Papillomavirus (HPV) Genotypes in Patients With High Grade Cervical Squamous Intraepithelial Lesion (HSIL) and Cervical Cancer From Croatia | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: DNA isolates from biopsy specimens of cervical lesions. |
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| 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. |
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| Condition ICMJE | Cervical Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | HPV HSIL cervical carcinoma | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Croatia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01385436 | ||||
| Other Study ID Numbers ICMJE | UHID-02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof Adriana Vince, MD, PhD, University Hospital for Infectious Diseases, Croatia | ||||
| Study Sponsor ICMJE | University Hospital for Infectious Diseases, Croatia | ||||
| Collaborators ICMJE | Merck | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital for Infectious Diseases, Croatia | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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