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NCT Number: NCT04226313

Self-sampling for Non-attenders to Cervical Cancer Screening

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with age 30-65 years; for arm A women > 65 years are allowed
  • Women live in the Czech Republic.
  • Women who have not participate in cervical cancer screening program in the Czech Republic for at least 3 years (Arm B and C).
  • Women with completed informed consent.
  • Women capable of self-sampling of cervicovaginal swab.

Exclusion criteria

  • Pregnant women.
  • Women with no sexual intercourse experience.
  • Women after hysterectomy including cervix.

Treatment and study plan

Self-sampling by Evalyn Brush

Diagnostic Test

Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush.

Self sampling by Evalyn Brush home or in GP´s clinic

Diagnostic Test

Women will perform a cervicovaginal self-sampling at their home or the GP´s clinic using Evalyn Brush

Primary outcomes

  1. Screening participation

    Time frame: 12 months

    Comparison of the percentages of women who return a cervicovaginal swab sampled by self-sampling device in different arms of the study. Identification of the best approach to address women who do not participate in standard cervical cancer screening program

  2. Prevalence of high-risk HPV

    Time frame: 12 months

    Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women within different arms of the study (attenders/non-attenders).

Secondary outcomes

  1. Sociodemographic characteristics

    Time frame: 12 months

    Comparison the distribution of sociodemographic characteristics (education, age, place of residence) and reasons for previous non-attendance for screening by intervention and attendance status in women who return a questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Marian Hajduch, MD, PhD.

CONTACT

[email protected]

+420 585 632 083

Vladimira Koudelakova, MSc, Ph.D.

CONTACT

[email protected]

+420 585 632 089

Sponsors and collaborators

Lead sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Other

Collaborators

  • National Institute for Cancer Research, Czech Republic

Registry information

Official study title

Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection

Acronym: KOPRETINA

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2020
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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