“Cervical cancer is one of the few tumors in which we know its cause, and that is the infection of cervical cells with certain serotypes of human papilloma virus (hrHPV – high-risk human papillomavirus). The incorporation of viral genetic material into the host genome is proven to have a direct link to cancerous transformation. The molecular mechanisms of this transformation are currently well described. The link between the HPV infection and the development of cervical cancer is so strong that in some European countries, HPV infection is gradually being tested under a screening method to identify women at risk for cervical cancer. Nevertheless, not all women infected with HPV, including the high-risk strains, undergo cancerous transformation. HPV infection activates the host’s immune system and the infection can disappear spontaneously. Research is currently focused on finding molecular features that could predict the virual behavior in an infected patient and identify those patients who are at such a high risk of cancerous transformation that they can benefit from invasive diagnostic or therapeutic procedures.”
The HPVSCREEN study is a pilot study conducted to verify the prevalence of infection of the female population with HPV viruses with a focus on the early and effective diagnosis of cervical cancer and the diseases that preceed it. The scientists evaluate the incidence of cervical HPV infection in a randomly selected group representing the population of women in two age groups (aged up to 30 and over 30 years) in different geographical areas of Slovakia.
The presented study is part of a project aimed at optimizing the strategy of screening for cervical cancer in the Slovak population. The result should be basic information on the prevalence of women infected with high-risk subtypes of HPV in the general population. After obtaining this information, it will be possible to design an optimized screening algorithm with regard to the most recent scientific knowledge and the introduction of a new screening scheme in developed countries (Germany, Great Britain, Australia) allowing early and effective diagnosis of one of the most common female cancers – cervical cancer.
The driving force behind the research project is the fact that despite there are widely available methods for screening, early diagnosis and treatment of precancerous lesions, cervical cancer is a disease which is among the 5 cancers with the highest incidence and mortality in women with severe social impact in Slovakia and internationally. The results of the study can therefore contribute essential information that can be applied not only locally but also globally.
The study involves:
- MEDIREX GROUP ACADEMY, n.o. but as the “Party implementing the research project”,
- approximately 30 centers, health care providers in the field of gynecology and obstetrics in Slovakia as an “Investigators”,
- 1000 patients from the Slovak Republic who met the admission and exclusion criteria of the study.
Enrolled patients will have a cervical swab collected and transferred to fluid in a Liquid Based Cytology ThinPrep® pap test collection container. Subsequently, the sample will be genetically tested for the presence of HPV viruses. After closing the laboratory diagnostic stage, the detected finding will be recorded in the online e-CRF system. No drug is validated in the study. This study is for observational purposes only and the schedule of outpatient visits, and all treatment regimens are determined by the attending physician in accordance with standard clinical practice.
The aim of the presented pilot study is to verify the prevalence of HPV cervical infection in a randomly selected population of women in two age groups (aged up to 30 and aged over 30) across different geographical areas of Slovakia. Preparation of a research plan with the aim of searching for effective screening and diagnostic methods.
Activities under the study
Recruitment of patients took place from 1. February to 31st December 2017. During this period, each patient who met the inclusion criteria (up to 1000) was included in the study.
Data collection on the patient population was terminated on 31. December 2017.Statistical processing and evaluation of the collected data takes place from 1. June 2017 to 1st June 2018.