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

Not Applicable

Completed

• Conditions: Cervical cancer; Cancer; Malignant neoplasm of cervix uteri

• Registration Number: ISRCTN71514910
• Lead Sponsor: Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan

Brief Summary

2018 Protocol article in http://romj.org/2018-0408 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31030478 results 2019 Results article in https://www.intechopen.com/online-first/results-of-a-survey-concerning-cervical-cancer-risk-factors-among-women-in-western-kazakhstan/ results 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31744375/ (added 24/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-12-31
• Study Start: 2018-01-02
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1166

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> All outcomes measured at the single study visit:<br> 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)<br> 2. Colposcopic data – correlation between HPV viral load and points of the RCI (Reid colposcopic index)<br> 3. Overall trend of CC morbidity in the region and in each age category<br> 4. CC prognostic incidence for the nearest period<br> 5. Detection of various HPV gene L1 isolates circulating in the region<br>