About the project
The study is aimed at verifying the sensitivity and specificity of cytological methods of prevention and early diagnosis of cervical cancer and diseases that precede it.
„The study evaluates the potential benefits of novel diagnostic methods, their advantages and disadvantages compared to conventional cytology. We anticipate that the results obtained in the study will lead to the formulation of general guidelines for screening tests with cervical swabs and will contribute to improving the prognosis of patients.“
Cervical cancer is a severe disease that mainly affects young women. Around 600 patients are identified in Slovakia every year, a third of whom will eventually succumb to the disease. It is caused by a persistent infection by human papillomavirus (HPV), which can be detected by primary prevention during regular gynecological check-ups. Regular preventive check-ups allows early detection of the potential pre-cancerous condition even before it develops into invasive cancer. it is therefore extremely important that we constantly improve the diagnosis of cervical cancer, and thus increase the chances of effectively detecting patients endangered by this disease. Thanks to the large amount of new important insights gained in the LadyCare study, we are contiually approaching this goal.
Cervical cancer is the second most common type of cancer in women. It mainly affects young women aged 35-45. In Slovakia only, there are 500-600 patients with this type of cancer identified every year and about 200 of them will eventually succumb to this disease. Cervical cancer is a type of cancer caused by a persistent infection with human papillomavirus (HPV). HPV viruses are responsible for up to 99.7 percent of cervical cancer cases, and anyone can be infected with the virus.
Aims of the study:
The aim of the study is to evaluate the sensitivity and specificity of “Conventional Cytology” and Liquid-Based Cytology (LBC) using:
- Computer-assisted screening (Thin prep Imaging System),
- immunocytochemical test for the presence of p16 and ki67 specific markers in cytological swabs,
- genetic testing for the presence of mRNA of high-risk groups of HPV viruses and E6 / E7 oncogenes,
- use of immunocytochemical test of positive cytological results with dual p16 and ki67 antibody with simultaneous comparison of positive results of conventional and LBC cytology with genetic examination of mRNA (E6/E7 oncogenes).
At the same time, evaluation of the correlations of previous cytological examinations with biopsy findings from the cervix in patients who underwent surgical treatment of the disease.
Activities under the study
Recruitment of patients
During this period, any patient who meets the admission and exclusion criteria until 2,000 patients are included in the study.
Date: from 1.Fabruary 2015 to 31st, January 2017
Collection of data related to the group of patients.
It was completed on 31st March 2019
Statistical processing and evaluation of collected data
Date: from 1st April 2019 to 30th June 2019.