Clinical trial · Observational
HPV DNA Self-sampling in a General Practitioner's Office.
Benefit of Self-sampling for HPV DNA in a General Practitioner's Office to Improve Participation in Cervical Screening - The ASTRA Study.
NCT06253169CI-TRIAL-00076364ASTRAunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HPV Infection | — | UNRESOLVED | — |
| Precancerous Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV DNA self-test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Not participating in screening
- description
- 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.
- interventionNames
- Diagnostic Test: HPV DNA self-test
- label
- Participating in the screening
- description
- All women over 30 years of age who regularly participate in screening but have not had an HPV test in the last 3 years.
- interventionNames
- Diagnostic Test: HPV DNA self-test
Primary outcomes (3)
- measure
- To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall.
- timeFrame
- Through study completion, an average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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).
References
Publications (3)
- BACKGROUNDSlama 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. PMID 37751376
- BACKGROUNDSehnal B, Slama J. What next in cervical cancer screening? Ceska Gynekol. 2020 Winter;85(4):236-243. PMID 33562978
- BACKGROUNDNgo 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. PMID 38224266