Cervical Cancer Screening Using Self-sampling Approach: Validation of Human Papillomavirus Self-sampling Kits Among Kazakhstani Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Self-sampling device acceptance
研究概览
简要总结
Prevention of cervical cancer is one of the priority areas of the Comprehensive Plan to Combat Cancer in the Republic of Kazakhstan for 2023-2027. High-risk human papillomavirus (HR-HPV) infections cause a wide variety of benign and malignant conditions, including cervical cancer. More than 90% of cervical cancer cases are attributed to HR-HPV infections, with HPV-16 and HPV-18 being reported to cause 70-75% of cases. At the present time, cervical cancer remains the fourth most prevalent cancer among women worldwide. Moreover, the majority of cervical cancer cases (90%) occur in low- and middle-income countries (LMICs), where cervical cancer remains the leading cause of death from cancer. Each year, the number of cervical cancer cases is dynamically increasing globally. Between 2000 and 2020 the absolute number of cervical cancer cases increased from 471 000 to 600 000. In 2020, there were around 350,000 deaths from cervical cancer. Moreover, by 2030 it is estimated that the number of new cervical cancer cases will reach 700 000, and the annual number of deaths will reach 400 000. Therefore, given such a significant annual increase in the number of cases and deaths, the elimination of cervical cancer is a global public health challenge.
The prevalence of HPV infection in Kazakhstan is high, around 39% among women attending gynecological clinics. Consequently, the cervical cancer incidence in Kazakhstan has increased over the past decade, and cervical cancer is the second leading cancer type among women in the country. Moreover, among Central Asian countries, Kazakhstan has the second-highest incidence rate of cervical cancer. The cervical cancer screening program is covered by the government and utilizes Papanicolaou test (Pap-test) performed by gynecologists in outpatient clinics all over the country. However, the screening coverage was reported to be low, covering only around 46% of the eligible population, and does not reach the demand level of 70% suggested by the World Health Organization (WHO). Furthermore, the national HPV vaccination program has just started in September 2024 and could contribute to the reduction of cervical cancer incidence only in the coming 10 years when the effect of vaccination will have an impact on the decrease of HPV prevalence in the country. A proper cervical cancer screening and screening coverage play a crucial role in cervical cancer prevention and control. Thus, there are many factors found to have an impact on overall screening behavior among Kazakhstani women and the increasing incidence of cervical cancer in the country. However, the current screening practices do not show high efficacy due to low coverage and general low sensitivity of the method used. These factors result in growing cervical cancer incidence in Kazakhstan. Thus, there is an emergent need to improve the screening process by introducing novel and reliable methods of screening. Cervical self-sampling could potentially improve the screening coverage; however, the approach should be validated to prove its effectiveness in the Kazakhstani cultural setting before introduction to the healthcare system.
详细描述
Study subjects and sample size. The study will be performed in the Nazarbayev University School of Medicine (NUSOM) in collaboration with other local medical universities and institutions.
This will be a cross-sectional study involving women attending outpatient clinics in Kazakhstani major cities, who will be recruited into the study to validate the HPV self-sampling kits. The project timeline is - January 2025-December 2027. We plan to invite 1000 women for a validation study: all women will complete a questionnaire after self-collection of a smear using kits.
Inclusion criteria: Eligible participants will be recruited from different outpatient clinics in Kazakhstan located in the different regions (western, eastern, northern, southern, and central parts) of the country, and must meet the following inclusion criteria: (1) age - women 18 years and older; (2) Intact uterine cervix (no prior total hysterectomy or trachelectomy); (3) ability to understand and answer questions/surveys in Kazakh, Russian or English.
Exclusion criteria: patients who are (1) younger than 18 years old, (2) women after total hysterectomy (or other surgery, when the uterine cervix is removed), (3) pregnant women, and (4) those who are not able to answer questions in Kazakh, Russian or English will be excluded.
Recruitment process. The recruitment will be done via trained and experienced outpatient gynecologists. After a careful explanation of the study's aims, all women who agreed to participate will be recruited and asked to sign an informed consent form. Further, they will (1) undergo a cervical sampling performed by the gynecologist ("gold standard" sampling), and (2) all women recruited into the study will be provided with different self-sampling kits (Evalyn Brush and Copan self-sampling swab, or Evalyn Brush and BGI Sentis HPV card) and written (picture-based) instruction to use the sampling kits. A patient will have to perform a self-sample based on the instruction and return the kits to the provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Eligible participants will be recruited from different outpatient clinics in Kazakhstan located in the different regions (western, eastern, northern, southern, and central parts) of the country, and must meet the following inclusion criteria:
- •age - women 18 years and older;
- •Intact uterine cervix (no prior total hysterectomy or trachelectomy);
- •ability to understand and answer questions/surveys in Kazakh, Russian or English.
排除标准
- •patients who are
- •younger than 18 years old,
- •women after total hysterectomy (or other surgery, when the uterine cervix is removed),
- •pregnant women, and
- •those who are not able to answer questions in Kazakh, Russian or English will be excluded.
研究组 & 干预措施
Validation of self-sampling devices
干预措施: Self-sampling acceptance (Behavioral)
结局指标
主要结局
Self-sampling device acceptance
时间窗: 18 months
To assess acceptance of self-sampling modality for cervical cancer screening in Kazakhstan, various self-sampling devises will be tested: 1. Evalyn Brush (https://www.roversmedicaldevices.com/cell-sampling-devices/evalyn-brush/). 2. Copan Self Vaginal FLOQSwabs (https://www.copangroup.com/product-ranges/self-floqswabs/) is a tube with a cotton swab. 3. BGI Sentis HPV self-sampling kit (https://www.bgi.com/global/molecular-genetics/sentis-oncology/bgi-sentistm-hpv-test/). These self-sampling kits will be distributed among the study participants who will be asked to fill surveys: : 1) patients' socio-demographic (age, education, residence, income) and clinical data (age at menarche, number of children, gynecological and non-gynecological conditions in the past medical history, etc.); 2) and survey to assess acceptability of HPV self-sampling and different self-sampling kits.
次要结局
未报告次要终点