NCT04226313

Self-sampling for Non-attenders to Cervical Cancer Screening

Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15,000 (estimated)
• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The trial will evaluate whether self-sampling and human papillomavirus (HPV) testing may increase cervical cancer screening attendance among under-screened women in Czech Republic. Different ways of offering self-sampling device will be evaluated.

Detailed description

Despite the existence of an effective cervical cancer screening in the Czech Republic, cervical cancer is the cause of about 800 new cases and 400 deaths every year. One of the major problem of the Czech cervical cancer screening is low participation. An effective strategy to increase cervical cancer screening attendance is one of the main challenges. The offering of self-sampling to the cervical cancer screening non-attenders could increase women's participation as was shown in several European countries. The trial should determine acceptability of the self-sampling followed by HPV DNA test by Czech women and therefore usability of the self-sampling device to increase cervical cancer screening attendance among under-screened women. Three different approaches will be tested: women will receive a self-sampling device by mail (Arm A); receive a self-sampling device by gynecologist (Arm B); receive a self-sampling device by general practitioner (Arm C). Comparisons of the screening attendance among the arms will be made. To address also potential effects on inequities, the analyses will include comparisons by sociodemographic characteristics. Women from the database of commercial vendor will be included to the Arm A regardless of whether or not they participate in cervical cancer screening program. Women who do not participate in cytology-based cervical cancer screening program for at least three years will be included through their gynecologist (Arm B) or general practitioner (Arm C) database. The second focus of the trial is the evaluation of high-risk human papillomavirus prevalence in screening population of Czech women (attenders and non-attenders of cervical cancer screening) since there are no relevant data for the Czech Republic. Study participants may volunteer for archiving of remaining biological materials for future studies.

Conditions

• Cervical Cancer
• Cervical Dysplasia
• Human Papillomavirus Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Self-sampling by Evalyn Brush	Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush.
DIAGNOSTIC_TEST	Self sampling by Evalyn Brush home or in GP´s clinic	Women will perform a cervicovaginal self-sampling at their home or the GP´s clinic using Evalyn Brush

Timeline

• Start date: 2019-09-23
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-01-13
• Last updated: 2026-03-23

Locations

1 site across 1 country: Czechia