Effectiveness of Cervical Screening in HPV Vaccinated Women
NCT ID: NCT02149030
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
6958 participants
INTERVENTIONAL
2014-03-31
2025-01-31
Brief Summary
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Detailed Description
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Cervical samples and cervico-vaginal self-samples rinsed in first-void urine will be analysed for HPV and C. trachomatis DNA with MGP primer system followed by MALDITOF mass spectrometry on the SEQUENOM platform (HPV) and the Abbott™ PCR (Chlamydia trachomatis), respectively.
With assumed \>50% participation the trial has 80% power to show non-inferiority of the infrequent vs. the frequent screening information.
A one-way (participant) blinded interim analysis among the 1992-born study participants in A1 and A3 arms, who have attended the 2nd study visit at the age of 25 years, will be performed in 2017 for assuring no statistically significant differences in the cervical intraepithelial neoplasia grade 2/3 (CIN2/CIN3) incidences of the two arms.
At the study end testing the null hypotheses of no difference in the incidence of the CIN2/3 end-points between the A1 and A2 intervention arms will be done using the Mantel-Haenszel one degree of freedom chi-square statistics.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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A1
A1) Cytological screening in A1 and A3. Frequent information of screening results for cytology and/or HPV DNA at the ages of 22 (cytology only), 25 and 30.
Cytological screening in A1 and A3
Cytological screening.
A2
A2) infrequent information of screening results, only at the age 30 years.
No interventions assigned to this group
A3
A3) Cytological screening in A1 and A3. With at least 1000 participants is enrolled for interim safety analysis when the 1992 birth cohort is 25 years of age and cytology results are being revealed.
Cytological screening in A1 and A3
Cytological screening.
Interventions
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Cytological screening in A1 and A3
Cytological screening.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
22 Years
22 Years
FEMALE
Yes
Sponsors
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European Union
OTHER
Academy of Finland
OTHER
Cancer Society of Finland
UNKNOWN
Tampere University
OTHER
Responsible Party
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Matti Lehtinen
Professor
Principal Investigators
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Matti Lehtinen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tampere University
Locations
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Nuorisotutkimusasema: Tampereen yliopisto
Äänekoski, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Hämeenlinna, , Finland
HUS
Helsinki, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Hyvinkää, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Iisalmi, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Jämsä, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Joensuu, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Jyväskylä, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Kajaani, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Kemi, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Kokkola, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Kotka, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Kouvola, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Kuopio, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Lahti, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Lappeenranta, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Lohja, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Mikkeli, , Finland
THL
Oulu, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Pori, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Porvoo, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Rauma, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Rovaniemi, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Salo, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Savonlinna, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Seinäjoki, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Tampere, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Turku, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Vaasa, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Vammala, , Finland
Nuorisotutkimusasema: Tampereen yliopisto
Varkaus, , Finland
Countries
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References
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Vanska S, Luostarinen T, Baussano I, Apter D, Eriksson T, Natunen K, Nieminen P, Paavonen J, Pimenoff VN, Pukkala E, Soderlund-Strand A, Dubin G, Garnett G, Dillner J, Lehtinen M. Vaccination With Moderate Coverage Eradicates Oncogenic Human Papillomaviruses If a Gender-Neutral Strategy Is Applied. J Infect Dis. 2020 Aug 17;222(6):948-956. doi: 10.1093/infdis/jiaa099.
Louvanto K, Eriksson T, Gray P, Apter D, Baussano I, Bly A, Harjula K, Heikkila K, Hokkanen M, Huhtinen L, Ikonen M, Karttunen H, Nummela M, Soderlund-Strand A, Veivo U, Dillner J, Elfstom M, Nieminen P, Lehtinen M. Baseline findings and safety of infrequent vs. frequent screening of human papillomavirus vaccinated women. Int J Cancer. 2020 Jul 15;147(2):440-447. doi: 10.1002/ijc.32802. Epub 2019 Dec 16.
Gray P, Kann H, Pimenoff VN, Eriksson T, Luostarinen T, Vanska S, Surcel HM, Faust H, Dillner J, Lehtinen M. Human papillomavirus seroprevalence in pregnant women following gender-neutral and girls-only vaccination programs in Finland: A cross-sectional cohort analysis following a cluster randomized trial. PLoS Med. 2021 Jun 7;18(6):e1003588. doi: 10.1371/journal.pmed.1003588. eCollection 2021 Jun.
Kalliala I, Eriksson T, Aro K, Hokkanen M, Lehtinen M, Gissler M, Nieminen P. Preterm birth rate after bivalent HPV vaccination: Registry-based follow-up of a randomized clinical trial. Prev Med. 2021 May;146:106473. doi: 10.1016/j.ypmed.2021.106473. Epub 2021 Feb 24.
Lehtinen M, Gray P, Louvanto K, Vanska S. In 30 years, gender-neutral vaccination eradicates oncogenic human papillomavirus (HPV) types while screening eliminates HPV-associated cancers. Expert Rev Vaccines. 2022 Jun;21(6):735-738. doi: 10.1080/14760584.2022.2064279. Epub 2022 Apr 15. No abstract available.
Lehtinen M, Pimenoff VN, Nedjai B, Louvanto K, Verhoef L, Heideman DAM, El-Zein M, Widschwendter M, Dillner J. Assessing the risk of cervical neoplasia in the post-HPV vaccination era. Int J Cancer. 2023 Mar 15;152(6):1060-1068. doi: 10.1002/ijc.34286. Epub 2022 Oct 10.
Pimenoff VN, Gray P, Louvanto K, Eriksson T, Lagheden C, Soderlund-Strand A, Dillner J, Lehtinen M. Ecological diversity profiles of non-vaccine-targeted HPVs after gender-based community vaccination efforts. Cell Host Microbe. 2023 Nov 8;31(11):1921-1929.e3. doi: 10.1016/j.chom.2023.10.001.
Lehtinen M, Bruni L, Elfstrom M, Gray P, Logel M, Mariz FC, Baussano I, Vanska S, Franco EL, Dillner J. Scientific approaches toward improving cervical cancer elimination strategies. Int J Cancer. 2024 May 1;154(9):1537-1548. doi: 10.1002/ijc.34839. Epub 2024 Jan 9.
Lehtinen M, Elfstrom M, Vanska S, Dillner J. Elimination of cervical cancer by refined vaccination and screening. Int J Cancer. 2025 Feb 15;156(4):886-888. doi: 10.1002/ijc.35228. Epub 2024 Oct 25. No abstract available.
Louvanto K, Verhoef L, Pimenoff V, Eriksson T, Leppala S, Lagheden C, Gray P, Scibior-Bentkowska D, Sumiec E, Nieminen P, Dillner J, Berkhof J, Meijer CJLM, Lehtinen M, Nedjai B, Heideman DAM. Low methylation marker levels among human papillomavirus-vaccinated women with cervical high-grade squamous intraepithelial lesions. Int J Cancer. 2024 Nov 1;155(9):1549-1557. doi: 10.1002/ijc.35044. Epub 2024 May 27.
Taavela K, Eriksson T, Huhtala H, Bly A, Harjula K, Heikkila K, Hokkanen M, Nummela M, Kotaniemi-Talonen L, Lehtinen M, Louvanto K. The quality of life of frequently vs. infrequently screened HPV vaccinated women. Qual Life Res. 2024 Apr;33(4):941-949. doi: 10.1007/s11136-023-03575-y. Epub 2024 Jan 18.
Lehtinen M, Apter D, Baussano I, Eriksson T, Natunen K, Paavonen J, Vanska S, Bi D, David MP, Datta S, Struyf F, Jenkins D, Pukkala E, Garnett G, Dubin G. Characteristics of a cluster-randomized phase IV human papillomavirus vaccination effectiveness trial. Vaccine. 2015 Mar 3;33(10):1284-90. doi: 10.1016/j.vaccine.2014.12.019. Epub 2015 Jan 12.
Other Identifiers
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HPV-004
Identifier Type: -
Identifier Source: org_study_id
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