Epidemiological analysis of human papillomavirus in western Kazakhstan in relation to HPV-attributable cervical pathology – social, clinical and genetic aspects

• Register: ISRCTN
• Last refreshed on: 6 March 2023
• Main ID: ISRCTN71514910
• Date of registration: 02/01/2018
• Prospective Registration: No
• Primary sponsor: Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
• Public title: Epidemiological analysis of human papillomavirus in western Kazakhstan in relation to HPV-attributable cervical pathology – social, clinical and genetic aspects
• Scientific title: Epidemiological analysis of human papillomavirus in western Kazakhstan in relation to HPV-attributable cervical pathology – social, clinical and genetic aspects
• Date of first enrolment: 01/04/2015
• Target sample size: 1152
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN71514910
• Study type: Observational
• Study design: Survey, cross-sectional study and case-control study (Screening)
• Phase: Not Applicable

Countries of recruitment

Kazakhstan

Contacts

• Name: Yerbol Bekmukhambetov

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria for the cross-sectional study:
1. Age 18-60 years
2. Presence of pathology of the cervix of any degree of severity, including minimal, suitable for colposcopy
3. Resident of Western Kazakhstan of any ethnicity
4. Absence of vaccination in the anamnesis

Inclusion criteria for the case-control study:
1. All consonants to participate in the study were selected amongst women with a newly diagnosed cervical cancer
2. Any age
3. Any stage of the process
4. Histological verification of the diagnosis

Exclusion criteria:
Exclusion criteria for the cross-sectional study:
1. Non-residents
2. Vaccinated
Note: HIV, 1 trimester pregnancy till 10-11 weeks are not exclusion criteria

Exclusion criteria for the case-control study:
1. Non-residents of Western Kazakhstan
2. Previous medical intervention - radiotherapy, chemotherapy, surgical treatment


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical cancer
Cancer
Malignant neoplasm of cervix uteri

Intervention(s)

Overall, two large groups for comparison are provided by the cross-sectional study: HPV carriers vs. not HPV-infected subjects with consequent analysis of all aspects: data on risk factors obtained by the interview; cytological data compared in groups HPV carriers vs. not HPV-infected subjects with adequate analysis of HPV findings amongst normal cytology and further towards CIN-III. Data on different methods (LBC CellScan vs. conventional cytological method) are compared, involving all obtained histological findings and colposcopic data with accomplished biopsy when supposed CIN.

The cross-sectional study and survey amongst general female population aged 18-60 is conducted on the basis of medical institutions (outpatient clinics). For scope different categories of patients to achieve maximally representative sample and minimize possible bias, state, insurance and private medical organizations are included. Women are recruited from the general population living in the region of Western Kazakhstan - in cities of regional importance, small towns, suburbs and immediate neighborhoods.

For the case-control study, all consonants to participate in the study are selected amongst women with a newly diagnosed cervical cancer, on the basis of the regional oncologic dispensaries. Randomisation is not performed. The design of the CC case-control study also suggested conducting a survey to identify the role of the main risk factors for cervical cancer, a similar taking of the material for HPV PCR-typing and for cytological testing using LBC and traditional methods (Romanovsky-Giemsa). Colposcopy was not performed when the advanced stages of cervical cancer.

The algorithm for women examining:
1. Compil

Primary Outcome(s)

All outcomes measured at the single study visit:
1. Total HPV prevalence and in the each province of the region
2. Average viral load in HPV carriers, both in general population and in CC diseased
3. HPV leading types in general population and in CC diseased
4. % of women-carriers of HR-HPV genotypes in each age category
5. % and distribution of HPV different types in normal cytology
6. The most significant risk factors for the CC implementation
7. Probability of cervical cancer decrease (odds ratio)

Secondary Outcome(s)

All outcomes measured at the single study visit:
1. Results of comparison of two cytological methods operating in the region (amount of non-informative material by each method; degree of concordance with histological conclusions in each method; results of ROC analysis; Kappa statistics)
2. Colposcopic data – correlation between HPV viral load and points of the RCI (Reid colposcopic index)
3. Overall trend of CC morbidity in the region and in each age category
4. CC prognostic incidence for the nearest period
5. Detection of various HPV gene L1 isolates circulating in the region

Secondary ID(s)

0115??01224

Source(s) of Monetary Support

Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan (Grant No. 2230/GF4)

Ethics review

Status:
Approval date:
Contact:

West Kazakhstan Marat Ospanov State Medical University’s Institutional Review Board, 10/09/2014, Protocol No. 3

Results

• Results available: Yes
• Date Completed: 31/12/2017