Clinical trial · Interventional
Trial23 - A Method Study on Cervical Screening in Women Offered HPV-vaccination as Girls
Trial23 - A Method Study on the Use of Primary HPV-testing With Cytology Triage in Women Offered HPV-vaccination as Girls
NCT03049553CI-TRIAL-00061957unknownN/AClinicalTrials.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)
In Denmark, the first birth cohorts of women offered HPV-vaccination as girls are entering the cervical screening program. These women are expected to be better protected against cervical cancer. It has not yet been decided how to screen these women. This method study will investigate a possible screening scheme that could provide a reduced burden of screening for HPV-vaccinated birth cohorts.
Conditions
Conditions (1)
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 Intraepithelial Neoplasia (CIN) | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cobas HPV-DNA test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- HPV-test
- description
- Cobas HPV-DNA test is performed on the cervical sample in addition to the routine cytology
- interventionNames
- Device: Cobas HPV-DNA test
- type
- NO_INTERVENTION
- label
- Routine
- description
- Screening with cytology as usual in the cervical screening program
Primary outcomes (1)
- measure
- Cumulative CIN3+ (cervical intraepithelial neoplasia grade 3 and above) in baseline screen-negative women.
- timeFrame
- After up to 9 years follow-up (end-of-study)
- description
- Histologically proven CIN3+ is chosen as primary outcome measure because it is the diagnostic threshold above which conization is recommended by the Danish Society of Gynecology and Obstetrics. Primary outcome will be based on intention-to-treat and per protocol analysis and stratified by region of residence. Primary HPV-testing with cytology triage every six years compared to cytology every three years will be approximated from the observed data.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 23 Years
- Maximum age
- 23 Years
Show eligibility criteria text
Inclusion Criteria: * Women born in 1994 living in the study area Exclusion Criteria: * None, as it is a public health trial
References
Publications (3)
- BACKGROUNDRonco G, Dillner J, Elfstrom KM, Tunesi S, Snijders PJ, Arbyn M, Kitchener H, Segnan N, Gilham C, Giorgi-Rossi P, Berkhof J, Peto J, Meijer CJ; International HPV screening working group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2014 Feb 8;383(9916):524-32. doi: 10.1016/S0140-6736(13)62218-7. Epub 2013 Nov 3. PMID 24192252
- BACKGROUNDDillner J, Rebolj M, Birembaut P, Petry KU, Szarewski A, Munk C, de Sanjose S, Naucler P, Lloveras B, Kjaer S, Cuzick J, van Ballegooijen M, Clavel C, Iftner T; Joint European Cohort Study. Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study. BMJ. 2008 Oct 13;337:a1754. doi: 10.1136/bmj.a1754. PMID 18852164
- DERIVEDThamsborg LH, Andersen B, Larsen LG, Christensen J, Johansen T, Hariri J, Christiansen S, Rygaard C, Lynge E. Danish method study on cervical screening in women offered HPV vaccination as girls (Trial23): a study protocol. BMJ Open. 2018 May 26;8(5):e020294. doi: 10.1136/bmjopen-2017-020294. PMID 29804060