Lady Care

Cervical cancer is a serious oncological disease that mainly affects young women. Every year, the number of women suffering from cervical cancer in Slovakia grows by 600 cases. One third of them eventually lose their fight with the disease. The disease is caused by a persistent human papillomavirus (HPV) infection, which can be detected at a regular gynecological check-up. Regular check-ups permit timely detection of the disease before it has a chance to develop into invasive carcinoma. Therefore, it is crucial for us to keep improving our methods of cervical cancer detection and thus increase our chances to effectively identify patients running the risk of being affected by the disease. Due to a large amount of knowledge acquired by the LadyCare study, we are getting closer and closer to our goal.

Cervical cancer is rated to be the second most frequent type of cancer in women. It affects mainly young women aged between 35 and 45. Every year, the number of women suffering from cervical cancer grows by 500 – 600 cases in Slovakia alone. About 200 of them eventually lose their fight with the disease. Cervical cancer is a type of oncological disease caused by a persistent human papillomavirus (HPV) infection. Human papillomaviruses are responsible for up to 99.7% of all cases of cervical cancer people can get infected by.

Infection by some types of HPV types (especially type 16, 18 and 31) can gradually cause some abnormal changes to the cervix, which might eventually result in the development of cancer. Identifying atypical, dysplastic changes to the cervix is the primary goal of regular gynecological check-ups and permits timely detection of the disease before it has a chance to develop into invasive carcinoma. Evaluating cervical smears on a cytological basis is the most essential diagnostic method.

In the last two decades, there has been a significant development of diagnostics in the area of cervical cell dysplasia. Cytodiagnostics makes use of automatic digital evaluation devices.

Apart from standard or “conventional” cytology based on smears on slides, new technology based on the examination of cervical cells in a liquid sample (LBC, Liquid-Based cytology) has been gaining ground. Unlike standard cytology, LBC permits the use of other modern screening methods, such as immunocytochemistry (detection of p16, Ki67, proteins activated during viral cell activation) or molecular biology techniques (detection of HPV genes, expression of E6 and E7 oncogenes activated by a viral infection).

The main purpose of the LadyCare study is to evaluate the potential benefits of LBC, i.e. its advantages and disadvantages compared to conventional cytology, based on a sample of 2,000 patients with positive results in the context of the Slovak Republic. Its main objective is to evaluate the efficiency of automatic cytodiagnostical devices used in LBC cytology. Along with the immunocytochemical and genetic screening mentioned above, the acquired cytodiagnostical results will be compared to the definitive histological diagnosis of the patient and subsequently evaluated in statistical terms. We expect the results of the LadyCare study will help us formulate a list of general recommendations for cervical smear screening.

 

“The study aims to evaluate the potential benefits of new diagnostic methods, their advantages and disadvantages, compared to conventional cytology. We expect the acquired results will help us make a list of general recommendations for cervical smear screening and contribute to patients’ better prospects.“

 

prof. MUDr. Pavel Babál, CSc.

Project Coordinator

Project Information

The main objective of the Lady Care study is to confirm the sensitivity and specificity of cytological prevention methods and timely detection of cervical cancer and preceding diseases.

The study aims to evaluate :

  • The sensitivity and specificity of “conventional cytology” and Liquid-Based cytology (LBC) using:
    • Computer-Assisted Screening („the Thin prep Imaging System“),
    • Imunocytochemical tests to detect the presence of specific p16 and ki67 markers in cytological smears,
    • Genetic tests to detect the presence of mRNA high-risk groups of HPV and E6/E7 oncogenes,
    • The use of imunocytochemical screening in the case of positive cytological tests using dual p16 and ki67 antibodies, and a comparison of the positive results of conventional cytology and LBC cytology with genetic mRNA tests (E6/E7 oncogenes).
  • Correlation between previous cytological tests and cervical biopsy in patients who have been operated due to the disease.

Subjects involved in the study:

MEDIREX GROUP ACADEMY n.o. as the “implementer of the research project”

30 centers – health care providers in gynecology and obstetrics in Slovakia as the “investigator”.

2,000 patients from Slovakia meeting the admission and exclusion criteria were gradually enrolled in the study.

Cytological cervical smears taken using what is called the split sample method, i.e. one single sample taken by a standardized sampling tool, will be first used for standard conventional cytological smears on glass slides, and the remaining sample material will be transferred into a liquid for a Liquid Based Cytology ThinPrep® pap test. Both smears will subsequently be independently examined by a cytologist.

For the purpose of the study, the patients will be cytologically monitored from their enrollment into the study until the end of data collection, i.e. during a period of 2 – 3 years, depending on the severity of the diagnosed changes (patients with positive results for ASCUS, L-SIL, ASC-H and H-SIL) in compliance with the standard and approved Guidelines, or until the patient is withdrawn from the study for other reasons.

Anamnesis and results are recorded in the eCRF system and subsequently evaluated.

After the conclusion of biopsy diagnostics, the detected biopsy findings (diagnosis) will be recorded on-line into the e-CRF system. Patient-related data collection will be concluded on 31st March, 2019.

No medicine has been tested by the study. This study is purely observational and the schedule of visits at the physician’s office as well as all treatment regimens have been determined by the attending physician in compliance with common clinical practice.

Partners

prof. MUDr. Miroslav Borovský, CSc.

The Head of the I. Clinic of Gynecology and Obstetrics, Medical Faculty of Comenius University and University Hospital Bratislava, Saints Cyril and Methodius Hospital

Ministry of Health Chief Specialist for Gynecology and Obstetrics

prof. MUDr. Pavel Babál, CSc.

Department of Pathology of the Medical Faculty, Comenius University and University Hospital Bratislava

Project Output

MEDIREX GROUP ACADEMY has launched labMED 03/15 research, which is unique in Slovakia

Activities

Patient Recruitment will be carried out between 1st February, 2015 and 31st January, 2017. Each patient meeting the admission and exclusion criteria will be enrolled in the study until we reach the total number of 2,000 patients.

Patient-related data collection will be concluded on 31st March, 2019.

Statistical processing and evaluation of the data collected will take place from 1st April, 2019 to 30th June, 2019.