Cervical CancerASTRANCT06253169
HPV DNA Self-sampling in a General Practitioner's Office.
An observational study of Cervical Cancer and HPV Infection, run by Patient Organization Veronica at 2 sites in Czechia.
Trial summary
One of the limitations of organized cervical screening in the Czech Republic is the lack of participation in preventive gynecological examinations. The aim of the project is to evaluate the benefits of self-sampling for HPV DNA in general practitioners' outpatient clinics to improve population participation in… Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Cervical Cancer, HPV Infection, Precancerous Lesion
- What is being tested?
- HPV DNA self-test
- How many people
- 2,000 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Mar 2024to Jun 2025
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women over 30 years of age who meet the entry criteria for inclusion in the study.
Who may be able to join
- Signed informed consent for statistical data processing and consent to the processing of personal data
- Age 30+
- HPV test never performed or performed more than 3 years ago or patient does not know
Who cannot join
- Refusal to participate
- Pregnancy and puerperium
- Menses
- History of hysterectomy
- HPV test performed <3 years ago with negative result
- Regular participation in screening and concurrent age 35, 45 or 55 years (test will be performed in the same year of screening).
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
CGOP, s.r.o.
Prague, 12000
Lucie Panýrová, PhD, +420 603 509 151, lucie.panyrova@next-clinics.com
Jiří Sláma, MD PhD
- Recruiting
Department of Gynecology, Obstetrics and Neonatology, General University Hospital, First Faculty of Medicine, Charles University
Prague, 12000
Jiří Sláma, MD PhD, +420224967451, jiri.slama@vfn.cz
Jiří Sláma, MD PhD
About this study
Official title: Benefit of Self-sampling for HPV DNA in a General Practitioner's Office to Improve Participation in Cervical Screening - The ASTRA Study.
One of the limitations of organized cervical screening in the Czech Republic is the lack of participation in preventive gynecological examinations. The aim of the project is to evaluate the benefits of self-sampling for HPV DNA in general practitioners' outpatient clinics to improve population participation in cervical screening.
Read the detailed description
Organized cervical screening in the Czech Republic has a long-term participation rate of about 56% of the target population. Despite active invitations through health insurance companies, a part of the population is resistant and does not participate in screening visits to gynaecologists in the long term. A significant proportion of such women, however, regularly visit their general practitioner due to other comorbidities. The aim of the ASTRA project is to assess whether an effective way to increase the proportion of women attending cervical screening is to perform self-testing for HPV DNA in the GP's office.
- Conditions
- Cervical Cancer, HPV Infection, Precancerous Lesion
- Being tested
- HPV DNA self-test
- Keywords
- Prevention, Cervical cancer, HPV test, Self-sampling
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV DNA self-testDiagnostic test
HPV DNA swab from the cervix performed by the patient herself.
| Study group | Role | What they receive |
|---|---|---|
| Not participating in screening | All women over 30 years of age who are not participating in screening or have not had a screening visit in less than 5 years. Receives: Diagnostic Test: HPV DNA self-test | |
| Participating in the screening | All women over 30 years of age who regularly participate in screening but have not had an HPV test in the last 3 years. Receives: Diagnostic Test: HPV DNA self-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall.
To compare the proportion of women who self-test for HPV DNA in a GP office versus those who refuse to take the test. To assess the overall proportion of women who self-test and the proportion in each study cohort.
Measured: Through study completion, an average of 1 year
Evaluation of the frequency of positivity of the HPV tests taken.
Compare the proportion of women who will self-test positive for HPV DNA, including an assessment of positivity for HPV 16/18 and other HPV genotypes. To assess the overall proportion of women testing positive and the proportion in each study cohort.
Measured: Through study completion, an average of 1 year
Evaluation of follow-up gynaecological care in women who tested positive.
To assess what proportion of women who self-test positive for HPV DNA will accept a gynecologic exam and to assess the results of the gynecologic visit.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patient Organization Veronica
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Veronika Cibulová, MS, Study chair, Patient Organisation Veronica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253169
- Sponsor's protocol ID
- V01
- Acronym
- ASTRA
- Status last verified
- Apr 2024
- First submitted
- 25 Jan 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All anonymised data will be available.
Publications
Slama J, Dvorak V, Trnkova M, Skrivanek A, Hrabcova K, Ovesna P, Novackova M. Is phased implementation of HPV testing and triage with dual staining the way to transform organized cytology screening? Eur J Cancer Prev. 2024 Mar 1;33(2):168-176. doi: 10.1097/CEJ.0000000000000844. Epub 2023 Sep 21.
PubMed 37751376Sehnal B, Slama J. What next in cervical cancer screening? Ceska Gynekol. 2020 Winter;85(4):236-243.
PubMed 33562978Ngo O, Chloupkova R, Cibula D, Slama J, Mandelova L, Hejduk K, Hajduch M, Minka P, Koudelakova V, Jaworek H, Trnkova M, Vanek P, Dvorak V, Dusek L, Majek O. Direct mailing of HPV self-sampling kits to women aged 50-65 non-participating in cervical screening in the Czech Republic. Eur J Public Health. 2024 Apr 3;34(2):361-367. doi: 10.1093/eurpub/ckad229.
PubMed 38224266
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Self-sampling for HPV DNA in a General Practitioner's Office to Improve Participation in Cervical Screening - The ASTRA Study.
- ClinicalTrials.gov ID
- NCT06253169
- Acronym / sponsor ID
- ASTRA / V01
- Conditions
- Cervical Cancer, HPV Infection, Precancerous Lesion
- Keywords
- Prevention, Cervical cancer, HPV test, Self-sampling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Patient Organization VeronicaOther government
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Feb 2024 (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.
One of the limitations of organized cervical screening in the Czech Republic is the lack of participation in preventive gynecological examinations. The aim of the project is to evaluate the benefits of self-sampling for HPV DNA in general practitioners' outpatient clinics to improve population participation in cervical screening.
Detailed description
Organized cervical screening in the Czech Republic has a long-term participation rate of about 56% of the target population. Despite active invitations through health insurance companies, a part of the population is resistant and does not participate in screening visits to gynaecologists in the long term. A significant proportion of such women, however, regularly visit their general practitioner due to other comorbidities. The aim of the ASTRA project is to assess whether an effective way to increase the proportion of women attending cervical screening is to perform self-testing for HPV DNA in the GP's office.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not participating in screening | – | Diagnostic Test: HPV DNA self-testAll women over 30 years of age who are not participating in screening or have not had a screening visit in less than 5 years. |
| Participating in the screening | – | Diagnostic Test: HPV DNA self-testAll women over 30 years of age who regularly participate in screening but have not had an HPV test in the last 3 years. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women over 30 years of age who meet the entry criteria for inclusion in the study.
Key inclusion criteria (3 listed)
- Signed informed consent for statistical data processing and consent to the processing of personal data
- Age 30+
- HPV test never performed or performed more than 3 years ago or patient does not know
Key exclusion criteria (6 listed)
- Refusal to participate
- Pregnancy and puerperium
- Menses
- History of hysterectomy
- HPV test performed <3 years ago with negative result
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 |
|---|---|---|
| HPV DNA self-testHPV DNA swab from the cervix performed by the patient herself. | Diagnostic test | Not participating in screening, Participating in the screening |
Primary outcome
To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall.
Time frame: Through study completion, an average of 1 year
To compare the proportion of women who self-test for HPV DNA in a GP office versus those who refuse to take the test. To assess the overall proportion of women who self-test and the proportion in each study cohort.
Evaluation of the frequency of positivity of the HPV tests taken.
Time frame: Through study completion, an average of 1 year
Compare the proportion of women who will self-test positive for HPV DNA, including an assessment of positivity for HPV 16/18 and other HPV genotypes. To assess the overall proportion of women testing positive and the proportion in each study cohort.
Evaluation of follow-up gynaecological care in women who tested positive.
Time frame: Through study completion, an average of 1 year
To assess what proportion of women who self-test positive for HPV DNA will accept a gynecologic exam and to assess the results of the gynecologic visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Background: PubMed 37751376Slama J, Dvorak V, Trnkova M, Skrivanek A, Hrabcova K, Ovesna P, Novackova M. Is phased implementation of HPV testing and triage with dual staining the way to transform organized cytology screening? Eur J Cancer Prev. 2024 Mar 1;33(2):168-176. doi: 10.1097/CEJ.0000000000000844. Epub 2023 Sep 21.
- Background: PubMed 33562978Sehnal B, Slama J. What next in cervical cancer screening? Ceska Gynekol. 2020 Winter;85(4):236-243.
- Background: PubMed 38224266Ngo O, Chloupkova R, Cibula D, Slama J, Mandelova L, Hejduk K, Hajduch M, Minka P, Koudelakova V, Jaworek H, Trnkova M, Vanek P, Dvorak V, Dusek L, Majek O. Direct mailing of HPV self-sampling kits to women aged 50-65 non-participating in cervical screening in the Czech Republic. Eur J Public Health. 2024 Apr 3;34(2):361-367. doi: 10.1093/eurpub/ckad229.
- Individual participant dataSharing planned: Undecided. All anonymised data will be available.
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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. This study is not recruiting at the moment.
Veronika Cibulová, MS study chair
Patient Organisation Veronica
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and HPV Infection, run by Patient Organization Veronica at 2 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 6 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiří Sláma, MD, PhD (+420224967451, jiri.slama@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall. (time frame: Through study completion, an average of 1 year). The study lists 3 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 NCT06253169, which also lists 3 linked publications.
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 Apr 2024.