Cervical Cancer Screening Via Self-sampling

NCT07111819 | Not Yet Recruiting

• 1 other identifier: AP26194759
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervical Cancer Screening

Keywords

Cervical cancer prevention; HPV; Cervical cancer screening; HPV self-sampling

Outcome Measures

Primary Outcomes (1)

• Self-sampling device acceptance

  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.

  18 months

Study Arms (1)

Validation of self-sampling devices

OTHER

Behavioral: Self-sampling acceptance

Interventions

Self-sampling acceptance BEHAVIORAL

Cervical self-sampling devices will be distributed among the study participants followed by survey on the devices acceptance

Validation of self-sampling devices

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Only female participants are allowed due to the nature of the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nazarbayev University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share