Cervical Intraepithelial Neoplasia Grade 2/3HPV-004NCT02149030
Effectiveness of Cervical Screening in HPV Vaccinated Women
A study testing Cytological screening in A1 and A3 in people with Cervical Intraepithelial Neoplasia Grade 2/3, run by Tampere University at 31 sites in Finland.
Trial summary
The main objective of the study is to identify whether or not being informed infrequently results about screening is: 1) At least as safe and accurate as frequently obtaining all information from the present combination of opportunistic/organized cervical screening by comparing regimen results of three screening… Read more about this study
- Who is it for?
- Ages 22 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 2/3
- What is being tested?
- Cytological screening in A1 and A3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,958 participants
- Where
- 31 sitesFinland
- Study dates
- Mar 2014to Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 22 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- HPV 16/18 vaccinated. Born 1992-1995.
Who cannot join
- Immunocompromising disease. HPV 6/11/16/18 vaccination.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Finland31 sites
Nuorisotutkimusasema: Tampereen yliopisto
Äänekoski
Nuorisotutkimusasema: Tampereen yliopisto
Hämeenlinna
HUS
Helsinki
Nuorisotutkimusasema: Tampereen yliopisto
Hyvinkää
Nuorisotutkimusasema: Tampereen yliopisto
Iisalmi
Nuorisotutkimusasema: Tampereen yliopisto
Jämsä
Nuorisotutkimusasema: Tampereen yliopisto
Joensuu
Nuorisotutkimusasema: Tampereen yliopisto
Jyväskylä
Nuorisotutkimusasema: Tampereen yliopisto
Kajaani
Nuorisotutkimusasema: Tampereen yliopisto
Kemi
Nuorisotutkimusasema: Tampereen yliopisto
Kokkola
Nuorisotutkimusasema: Tampereen yliopisto
Kotka
Nuorisotutkimusasema: Tampereen yliopisto
Kouvola
Nuorisotutkimusasema: Tampereen yliopisto
Kuopio
Nuorisotutkimusasema: Tampereen yliopisto
Lahti
Nuorisotutkimusasema: Tampereen yliopisto
Lappeenranta
Nuorisotutkimusasema: Tampereen yliopisto
Lohja
Nuorisotutkimusasema: Tampereen yliopisto
Mikkeli
THL
Oulu
Nuorisotutkimusasema: Tampereen yliopisto
Pori
Nuorisotutkimusasema: Tampereen yliopisto
Porvoo
Nuorisotutkimusasema: Tampereen yliopisto
Rauma
Nuorisotutkimusasema: Tampereen yliopisto
Rovaniemi
Nuorisotutkimusasema: Tampereen yliopisto
Salo
Nuorisotutkimusasema: Tampereen yliopisto
Savonlinna
Nuorisotutkimusasema: Tampereen yliopisto
Seinäjoki
Nuorisotutkimusasema: Tampereen yliopisto
Tampere
Nuorisotutkimusasema: Tampereen yliopisto
Turku
Nuorisotutkimusasema: Tampereen yliopisto
Vaasa
Nuorisotutkimusasema: Tampereen yliopisto
Vammala
Nuorisotutkimusasema: Tampereen yliopisto
Varkaus
About this study
Official title: Effectiveness of Cervical Screening in HPV Vaccinated Women - a Randomized Trial
The main objective of the study is to identify whether or not being informed infrequently results about screening is: 1) At least as safe and accurate as frequently obtaining all information from the present combination of opportunistic/organized cervical screening by comparing regimen results of three screening visits at the ages of 22, 25 and 30 years (Arm A1) vs. results of one screening visit at the age of 30 years (Arm A2) in Human papillomavirus (HPV) vaccinated young women.
Read the detailed description
Altogether 16.500 1992-1995 born women vaccinated with the bi-valent human papillomavirus type 16 and 18 (HPV16/18) vaccine as adolescents either at the age of 12 to 15 or at the age of 18 will be invited to an effectiveness trial at the age of 22 years, and randomized into Arms A1 and A2, and A3, respectively.
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.
- Being tested
- Cytological screening in A1 and A3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytological screening in A1 and A3Other
Cytological screening.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | 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. Receives: Other: Cytological screening in A1 and A3 |
| A2 | No intervention | A2) infrequent information of screening results, only at the age 30 years. |
| A3 | Other | 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. Receives: Other: Cytological screening in A1 and A3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of intraepithelial neoplasia grade 2/3 (CIN2/3).
1a) No marked difference in the incidence of CIN2/3 between arms A1 (participants frequently informed of the cytological results) and A3 (participants not informed of the cytological findings at the age of 22) (interim analysis). 1b) No difference in the incidence of CIN2/3 between arms A1 (participants frequently informed of the cytological results) and A2 (participants infrequently informed of the cytological results).
The participants will be followed for 9 years starting from the year they turn 22. For 1992 born the follow-up will start in 2014 and end in 2023. For 1995 born the follow-up will start in 2017 and end in 2026.
The interim analysis will include only 1992 cohort. The final analysis will include all cohorts (1992, 1993, 1994, 1995).
Measured: 2017-2020, i.e. four years (interim), 2021-2025, i.e. five years (final analysis). Participants will be followed for the duration of the study until 2026, an expected average of 9 years.
Secondary outcomes (1)
Type-replacement
Whether the post-vaccination distributions of vaccine-covered and/or non-vaccine covered HPV types develop differentially in the different vaccination arms by vaccination arm over time up to 15 years post vaccination.
Measured: 2021-2025, i.e. four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial Neoplasia Grade 2/3Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6,958 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, Academy of Finland, Cancer Society of Finland
- Responsible party
- Principal investigator, Matti Lehtinen, Tampere University
- Investigators
- Matti Lehtinen, MD, PhD, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149030
- Sponsor's protocol ID
- HPV-004
- Acronym
- HPV-004
- Status last verified
- Jan 2025
- First submitted
- 19 May 2014
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32161969Louvanto 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.
PubMed 31749143Gray 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.
PubMed 34097688Kalliala 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.
PubMed 33639181Lehtinen 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.
PubMed 35404177Lehtinen 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.
PubMed 36093582Pimenoff 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.
PubMed 37944494Lehtinen 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.
PubMed 38196123Lehtinen 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.
PubMed 39450703Louvanto 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.
PubMed 38801336Taavela 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.
PubMed 38238599Lehtinen 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.
PubMed 25593103
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cervical Screening in HPV Vaccinated Women - a Randomized Trial
- ClinicalTrials.gov ID
- NCT02149030
- Acronym / sponsor ID
- HPV-004 / HPV-004
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,958 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- European Union, Academy of Finland, Cancer Society of Finland
- Study start
- Mar 2014
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 29 May 2014 (estimated)
- 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.
The main objective of the study is to identify whether or not being informed infrequently results about screening is: 1) At least as safe and accurate as frequently obtaining all information from the present combination of opportunistic/organized cervical screening by comparing regimen results of three screening visits at the ages of 22, 25 and 30 years (Arm A1) vs. results of one screening visit at the age of 30 years (Arm A2) in Human papillomavirus (HPV) vaccinated young women.
Detailed description
Altogether 16.500 1992-1995 born women vaccinated with the bi-valent human papillomavirus type 16 and 18 (HPV16/18) vaccine as adolescents either at the age of 12 to 15 or at the age of 18 will be invited to an effectiveness trial at the age of 22 years, and randomized into Arms A1 and A2, and A3, respectively.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Other: Cytological screening in A1 and A3A1) 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. |
| A2 | No intervention | –A2) infrequent information of screening results, only at the age 30 years. |
| A3 | Other | Other: Cytological screening in A1 and A3A3) 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. |
Who may qualify
- Ages
- 22 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- HPV 16/18 vaccinated. Born 1992-1995.
Key exclusion criteria (1 listed)
- Immunocompromising disease. HPV 6/11/16/18 vaccination.
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 |
|---|---|---|
| Cytological screening in A1 and A3Cytological screening. | Other | A1, A3 |
Primary outcome
Occurrence of intraepithelial neoplasia grade 2/3 (CIN2/3).
Time frame: 2017-2020, i.e. four years (interim), 2021-2025, i.e. five years (final analysis). Participants will be followed for the duration of the study until 2026, an expected average of 9 years.
1a) No marked difference in the incidence of CIN2/3 between arms A1 (participants frequently informed of the cytological results) and A3 (participants not informed of the cytological findings at the age of 22) (interim analysis). 1b) No difference in the incidence of CIN2/3 between arms A1 (participants frequently informed of the cytological results) and A2 (participants infrequently informed of the cytological results). The participants will be followed for 9 years starting from the year they turn 22. For 1992 born the follow-up will start in 2014 and end in 2023. For 1995 born the follow-up will start in 2017 and end in 2026. The interim analysis will include only 1992 cohort. The final analysis will include all cohorts (1992, 1993, 1994, 1995).
1 secondary outcome
Type-replacement
Time frame: 2021-2025, i.e. four years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Background: PubMed 32161969Vanska 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.
- Background: PubMed 31749143Louvanto 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.
- Background: PubMed 34097688Gray 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.
- Background: PubMed 33639181Kalliala 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.
- Background: PubMed 35404177Lehtinen 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.
- Background: PubMed 36093582Lehtinen 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.
- Background: PubMed 37944494Pimenoff 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.
- Background: PubMed 38196123Lehtinen 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.
- Background: PubMed 39450703Lehtinen 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.
- Background: PubMed 38801336Louvanto 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.
- Background: PubMed 38238599Taavela 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.
- Background: PubMed 25593103Lehtinen 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.
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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.
Matti Lehtinen, MD, PhD principal investigator
Tampere University
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytological screening in A1 and A3 in people with Cervical Intraepithelial Neoplasia Grade 2/3, run by Tampere University at 31 sites in Finland.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Finland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Occurrence of intraepithelial neoplasia grade 2/3 (CIN2/3). (time frame: 2017-2020, i.e. four years (interim), 2021-2025, i.e. five years (final analysis). Participants will be followed for the duration of the study until 2026, an expected average of 9 years.). 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 NCT02149030, which also lists 12 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 20 Jan 2025.