Cervical CancerKOPRETINANCT04226313
Self-sampling for Non-attenders to Cervical Cancer Screening
A study testing Self-sampling by Evalyn Brush and Self sampling by Evalyn Brush home or in GP´s clinic in people with Cervical Cancer and Cervical Dysplasia, run by The Institute of Molecular and Translational Medicine, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Cervical Dysplasia, Human Papillomavirus Infection
- What is being tested?
- Self-sampling by Evalyn Brush and Self sampling by Evalyn Brush home or in GP´s clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteCzechia
- Study dates
- 23 Sep 2019to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women.
- Women with no sexual intercourse experience.
- Women after hysterectomy including cervix.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection
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.
Read the 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.
- Being tested
- Self-sampling by Evalyn Brush, Self sampling by Evalyn Brush home or in GP´s clinic
- Keywords
- human papillomavirus, HPV, self-sampling, cervicovaginal swab, cervical cancer screening, non-attendance
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-sampling by Evalyn BrushDiagnostic test
Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush.
Self sampling by Evalyn Brush home or in GP´s clinicDiagnostic test
Women will perform a cervicovaginal self-sampling at their home or the GP´s clinic using Evalyn Brush
| Study group | Role | What they receive |
|---|---|---|
| Self-sampling device sent at home | Active comparator | Women randomly selected from a commercial vendor database (both attenders and non-attenders) receive a mail inviting them to perform a cervicovaginal self-sampling at their home (with the device provided). Returned self-sampled swabs will be tested by CE-IVD-marked (Conformité Européenne, In Vitro Diagnostics) HPV diagnostic test validated for use in primary cervical cancer screening. The arm will include approx. 5000 participants. Receives: Diagnostic Test: Self-sampling by Evalyn Brush |
| Self-sampling device sent by gynecologist(s) | Experimental | Women selected from databases of cooperating gynecologists (non-attenders for at least 3 years) receive a mail inviting them to perform a cervicovaginal self-sampling at their home (with the device provided). Returned self-sampled swabs will be tested by CE-IVD-marked HPV diagnostic test validated for use in primary cervical cancer screening. The arm will include approx. 5000 participants. Receives: Diagnostic Test: Self-sampling by Evalyn Brush |
| Self-sampling device obtained from general practitioner(s) | Experimental | Women selected from databases of cooperating general practitioners (non-attenders for at least 3 years) receive a self-sampling device. Returned self-sampled swabs will be tested by CE-IVD-marked HPV diagnostic test validated for use in primary cervical cancer screening. The arm will include approx. 5000 participants. Receives: Diagnostic Test: Self sampling by Evalyn Brush home or in GP´s clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening participation
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
Measured: 12 months
Prevalence of high-risk HPV
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).
Measured: 12 months
Secondary outcomes (1)
Sociodemographic characteristics
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start23 Sep 2019
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Cancer Research, Czech Republic
- Responsible party
- Sponsor
- Investigators
- Marian Hajduch, MD, PhD., Study director, IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226313
- Sponsor's protocol ID
- 5850
- Acronym
- KOPRETINA
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2020
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection
- ClinicalTrials.gov ID
- NCT04226313
- Acronym / sponsor ID
- KOPRETINA / 5850
- Keywords
- human papillomavirus, HPV, self-sampling, cervicovaginal swab, cervical cancer screening, non-attendance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Collaborators
- National Institute for Cancer Research, Czech Republic
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-sampling device sent at home | Active comparator | Diagnostic Test: Self-sampling by Evalyn BrushWomen randomly selected from a commercial vendor database (both attenders and non-attenders) receive a mail inviting them to perform a cervicovaginal self-sampling at their home (with the device provided). Returned self-sampled swabs will be tested by CE-IVD-marked (Conformité Européenne, In Vitro Diagnostics) HPV diagnostic test validated for use in primary cervical cancer screening. The arm will include approx. 5000 participants. |
| Self-sampling device sent by gynecologist(s) | Experimental | Diagnostic Test: Self-sampling by Evalyn BrushWomen selected from databases of cooperating gynecologists (non-attenders for at least 3 years) receive a mail inviting them to perform a cervicovaginal self-sampling at their home (with the device provided). Returned self-sampled swabs will be tested by CE-IVD-marked HPV diagnostic test validated for use in primary cervical cancer screening. The arm will include approx. 5000 participants. |
| Self-sampling device obtained from general practitioner(s) | Experimental | Diagnostic Test: Self sampling by Evalyn Brush home or in GP´s clinicWomen selected from databases of cooperating general practitioners (non-attenders for at least 3 years) receive a self-sampling device. Returned self-sampled swabs will be tested by CE-IVD-marked HPV diagnostic test validated for use in primary cervical cancer screening. The arm will include approx. 5000 participants. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant women.
- Women with no sexual intercourse experience.
- Women after hysterectomy including cervix.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-sampling by Evalyn BrushWomen will perform a cervicovaginal self-sampling at their home using Evalyn Brush. | Diagnostic test | Self-sampling device sent at home, Self-sampling device sent by gynecologist(s) |
| Self sampling by Evalyn Brush home or in GP´s clinicWomen will perform a cervicovaginal self-sampling at their home or the GP´s clinic using Evalyn Brush | Diagnostic test | Self-sampling device obtained from general practitioner(s) |
Primary outcome
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
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).
1 secondary outcome
Sociodemographic characteristics
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marian Hajduch, MD, PhD. study director
IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-sampling by Evalyn Brush and Self sampling by Evalyn Brush home or in GP´s clinic in people with Cervical Cancer and Cervical Dysplasia, run by The Institute of Molecular and Translational Medicine, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marian Hajduch, MD, PhD. (+420 585 632 083, marian.hajduch@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening participation (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.