Cervical CancerHPVProNCT04133610
HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs
A study testing Self-sampling using digene HC2 DNA Collection Device and Self-sampling using Evalyn Brush in people with Cervical Cancer and Cervical Dysplasia, run by The Institute of Molecular and Translational Medicine, Czech Republic at 3 sites in Czechia.
Trial summary
Comparison of the detection of human papillomavirus DNA in paired physician-obtained cervical swabs and self-sampled cervicovaginal swabs and evaluation of HPV prevalence in Czech women screening population. Read more about this study
- Who is it for?
- Ages 30 to 64 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 using digene HC2 DNA Collection Device and Self-sampling using Evalyn Brush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,044 participants
- Where
- 3 sitesCzechia
- Study dates
- 1 Sep 2018to 25 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with age 30-64 years.
- Women attending cervical cancer screening program in Czech Republic.
- Women with completed informed consent.
Who cannot join
- Pregnant women.
- Women with no sexual intercourse experience.
- Women after cervical conization or hysterectomy.
- Women with CIN or cervical carcinoma in anamnesis.
- Women at risk of increased bleeding.
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
GYN-PREN, Ltd.
Frýdek-Místek
GYNPRENATAL, Ltd.
Havířov
MEDIOL, Ltd.
Olomouc
About this study
Comparison of the detection of human papillomavirus DNA in paired physician-obtained cervical swabs and self-sampled cervicovaginal swabs and evaluation of HPV prevalence in Czech women screening population.
Read the detailed description
The cervical screening program in the Czech Republic is based on cytology with HPV triage. Nevertheless, cytology-based cervical screening may switch to HPV-based cervical screening in future. The implementation of primary HPV screening and insuficiency cervical screening attendance are a major challenge. The offering of self-sampling to the cervical screening non-attenders could increase women's participation as was shown in several European countries. The objective of the HPVPro study was to find out the HPV prevalence in the screening population of Czech women since there are no data for the Czech Republic. The second objective was to compare HPV DNA detection rate in paired self-sampled cervicovaginal swabs and physician-obtained cervical swabs and to determine acceptability of self-sampling HPV DNA test by Czech women. This information is important for optimisation of cervical cancer screening program in the Czech Republic.
- Being tested
- Self-sampling using digene HC2 DNA Collection Device, Self-sampling using Evalyn Brush
- Keywords
- human papillomavirus, HPV, self-sampling, cervical swab, cervicovaginal swab, cervical cancer screening
- 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 using digene HC2 DNA Collection DeviceDiagnostic test
All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
Self-sampling using Evalyn BrushDiagnostic test
All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
| Study group | Role | What they receive |
|---|---|---|
| Self-sampling device in media | Experimental | Women will undergo clinician-obtained cervical swab and self-sampled cervicovaginal swab using self-sampling device in STM media. HPV will be detected by hybridization technique. Receives: Diagnostic Test: Self-sampling using digene HC2 DNA Collection Device |
| Dry self-sampling device | Experimental | Women will undergo clinician-obtained cervical swab and self-sampled cervicovaginal swab using dry self-sampling device. HPV will be detected by hybridization and PCR techniques. Receives: Diagnostic Test: Self-sampling using Evalyn Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV prevalence
Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women.
Measured: 18 months
Concordance of HPV positivity in self-collected cervicovaginal swabs and clinician-collected cervical swabs
Paired cervical and cervicovaginal swabs will be collected in the same day and will be tested by the same method. Concordance of HPV positivity in both swabs will be evaluated.
Measured: 18 months
Secondary outcomes (1)
Comparison of different human papillomavirus DNA detection methods in cervical and cervicovaginal swabs.
Hybridization and PCR-based HPV detection methods will be tested in both cervical and cervicovaginal swabs and results of these two methods will be compared.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Sep 2018
- Primary completion30 Oct 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,044 participants (actual)
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, Palacky University in Olomouc, Faculty of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133610
- Sponsor's protocol ID
- 343
- Acronym
- HPVPro
- Status last verified
- Nov 2019
- First submitted
- 16 Oct 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaworek H, Bouska O, Kourilova P, Hajduch M, Koudelakova V. High-risk HPV prevalence in the Czech cervical cancer screening population: a comparison of clinician-collected and self-collected sampling. Eur J Public Health. 2025 Aug 1;35(4):760-765. doi: 10.1093/eurpub/ckaf045.
PubMed 40194781
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs
- ClinicalTrials.gov ID
- NCT04133610
- Acronym / sponsor ID
- HPVPro / 343
- Keywords
- human papillomavirus, HPV, self-sampling, cervical swab, cervicovaginal swab, cervical cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,044 participants (actual)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Collaborators
- National Institute for Cancer Research, Czech Republic
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 21 Oct 2019 (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.
Comparison of the detection of human papillomavirus DNA in paired physician-obtained cervical swabs and self-sampled cervicovaginal swabs and evaluation of HPV prevalence in Czech women screening population.
Detailed description
The cervical screening program in the Czech Republic is based on cytology with HPV triage. Nevertheless, cytology-based cervical screening may switch to HPV-based cervical screening in future. The implementation of primary HPV screening and insuficiency cervical screening attendance are a major challenge. The offering of self-sampling to the cervical screening non-attenders could increase women's participation as was shown in several European countries. The objective of the HPVPro study was to find out the HPV prevalence in the screening population of Czech women since there are no data for the Czech Republic. The second objective was to compare HPV DNA detection rate in paired self-sampled cervicovaginal swabs and physician-obtained cervical swabs and to determine acceptability of self-sampling HPV DNA test by Czech women. This information is important for optimisation of cervical cancer screening program in the Czech Republic.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-sampling device in media | Experimental | Diagnostic Test: Self-sampling using digene HC2 DNA Collection DeviceWomen will undergo clinician-obtained cervical swab and self-sampled cervicovaginal swab using self-sampling device in STM media. HPV will be detected by hybridization technique. |
| Dry self-sampling device | Experimental | Diagnostic Test: Self-sampling using Evalyn BrushWomen will undergo clinician-obtained cervical swab and self-sampled cervicovaginal swab using dry self-sampling device. HPV will be detected by hybridization and PCR techniques. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with age 30-64 years.
- Women attending cervical cancer screening program in Czech Republic.
- Women with completed informed consent.
Key exclusion criteria (5 listed)
- Pregnant women.
- Women with no sexual intercourse experience.
- Women after cervical conization or hysterectomy.
- Women with CIN or cervical carcinoma in anamnesis.
- Women at risk of increased bleeding.
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 using digene HC2 DNA Collection DeviceAll women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab. | Diagnostic test | Self-sampling device in media |
| Self-sampling using Evalyn BrushAll women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab. | Diagnostic test | Dry self-sampling device |
Primary outcome
HPV prevalence
Time frame: 18 months
Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women.
Concordance of HPV positivity in self-collected cervicovaginal swabs and clinician-collected cervical swabs
Time frame: 18 months
Paired cervical and cervicovaginal swabs will be collected in the same day and will be tested by the same method. Concordance of HPV positivity in both swabs will be evaluated.
1 secondary outcome
Comparison of different human papillomavirus DNA detection methods in cervical and cervicovaginal swabs.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Derived from this study: PubMed 40194781Jaworek H, Bouska O, Kourilova P, Hajduch M, Koudelakova V. High-risk HPV prevalence in the Czech cervical cancer screening population: a comparison of clinician-collected and self-collected sampling. Eur J Public Health. 2025 Aug 1;35(4):760-765. doi: 10.1093/eurpub/ckaf045.
- Individual participant dataSharing planned: No
Related trials for Cervical Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
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. This study is not recruiting at the moment.
Marian Hajduch, MD, PhD. study director
Palacky University in Olomouc, Faculty of Medicine and Dentistry
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-sampling using digene HC2 DNA Collection Device and Self-sampling using Evalyn Brush in people with Cervical Cancer and Cervical Dysplasia, run by The Institute of Molecular and Translational Medicine, Czech Republic at 3 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV prevalence (time frame: 18 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?
On the ClinicalTrials.gov record for NCT04133610, which also lists 1 linked publication.
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 26 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.