Cervical Intraepithelial Neoplasia Grade 2/3HPV400NCT04755517
Effectiveness of Cervical Screening in Unvaccinated, Herd Effect Protected Women (HPV400)
A study testing Frequent information of cytological/ HPV DNA screening results in people with Cervical Intraepithelial Neoplasia Grade 2/3 and Adenocarcinoma in Situ, run by Tampere University Hospital at 18 sites in Finland.
Trial summary
To identify: 1) Whether being informed infrequently results about screening is at least as a) safe and b) accurate as frequently obtaining all information from (the present combination of opportunistic/organized) cervical screening by comparing regimen results of two screening visits at the ages of 25 and 28 years… Read more about this study
- Who is it for?
- Ages 25 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 2/3, Adenocarcinoma in Situ
- What is being tested?
- Frequent information of cytological/ HPV DNA screening results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,000 participants
- Where
- 18 sitesFinland
- Study dates
- 9 Jun 2020to 31 Dec 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 25 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Born 1995-1997. 25 years of age residence in one of the eight community-randomized trial A communities with documented herd effect from gender-neutral vaccination or C communities devoid of the herd effect.
Who cannot join
- Immune compromising disease status (e.g. transplant recipients). HPV vaccination
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
Finland18 sites
HPV-tutkimukset
Hämeenlinna, 40100
HUS
Helsinki
HPV-tutkimukset
Iisalmi, 74100
HPV-tutkimukset
Joensuu, 80100
HPV-tutkimukset
Jyväskylä, 40100
Nuorisotutkimusasema, PSHP/ Tampereen yliopisto
Kemi, 94100
Nuorisotutkimusasema, PSHP/Tampereen yliopisto
Kotka, 48100
HPV-tutkimukset
Kouvola, 45100
Nuorisotutkimusasema, PSHP; Tampereen yliopisto
Kuopio, 70100
Nuorisotutkimusasema, PSHP/ Tampereen yliopisto
Lahti, 15110
HPV-tutkimukset
Oulu, 90100
HPV-tutkimukset
Pori, 28100
HPV-tutkimukset
Porvoo, 06100
Nuorisotutkimusasema, PSHP; Tampereen yliopisto
Rauma, 26100
HPV-tutkimukset
Sastamala, 38200
HPV-tutkimukset
Seinäjoki, 60100
Nuorisotutkimusasema; PSHP/ Tamereen yliopisto
Tampere, 33100
HPV-tutkimukset
Varkaus, 78300
About this study
Official title: Effectiveness of Cervical Screening in Unvaccinated, Herd Effect Protected Women - A Randomized Trial
To identify: 1) Whether being informed infrequently results about screening is at least as a) safe and b) accurate as frequently obtaining all information from (the present combination of opportunistic/organized) cervical screening by comparing regimen results of two screening visits at the ages of 25 and 28 years (Arm A1) vs. results of one screening visit at the age of 28 years (Arm A2) in unvaccinated herd effect protected women. Unvaccinated, frequently screened women, who are not under herd effect protection will be controls (C).
Read the detailed description
Altogether 14.000 1995-1997 born women resident in communities where herd effect against high-risk HPV infections was created with gender-neutral vaccination of birth cohorts 1992-1995 (A-communities) or not (control C-communities) in 2007-2010 with the bi-valent HPV16/18 vaccine will be invited to participate a randomized screening trial at the ages of 25 and 28 years.
Cervical samples will be analysed for HPV DNA with MGP (Modified General Primer) primer system followed by MALDITOF(matrix assisted laser desorption ionization-time of flight mass spectrometry) mass spectrometry on the SEQUENOM (translation of genomic science into solutions for molecular medicine and biomedical research) platform (HPV).
With assumed 65% and 90% participation and retain rates the trial has 80% power to show non-inferiority of the infrequent vs. the frequent screening information.
At the study-end testing the null hypotheses of no difference in the incidence of the CIN2/3 (cervical squamous intraepithelial neoplasia 2/3) end-points comparing the A1 vs. C and A2 vs. C intervention arms will be done using the Mantel-Haenszel one degree of freedom chi-square statistics.
Work Content Letters of invitation to visit cervical screening at the nearest FICAN (Comprehensive Cancer Center Finland)-Mid study site will be send to the approximately 14.000 unvaccinated women at the ages of 25 and 28 years Following informed consent cervical liquid-based cytology samples will be taken for HPV DNA and/or cytology screening at study visits.
All cytological screening results will be communicated to Arm A1 and Arm C study participants. Arm A2 participants will get the test results at the age of 28. However, results of the cytology testing indicative of colposcopy according to local standard of care and currently accepted EU (the European Union) -guidelines (Käypä Hoito 2010, Franceschi et al. 2011) will be immediately communicated to all study participants. HPV DNA results will be communicated to all study participants at the study end. Pertinent colposcopy referrals to organized health care will be made.
All study participants will be offered a possibility to give an oropharyngeal sputum sample after 30 seconds gargling of sterile physiological saline (5 ml) for HPV PCR (polymerase chain reaction) analysis.
- Being tested
- Frequent information of cytological/ HPV DNA screening results
- Keywords
- Cervical Intraepithelial Neoplasia, Neoplasms, Carcinoma in Situ, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Adenocarcinoma in situ
- Medical subject headings
- Adenocarcinoma in Situ, Uterine Cervical Dysplasia, Neoplasms, Carcinoma in Situ, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequent information of cytological/ HPV DNA screening resultsOther
All participants will be referred to pertinent diagnosis and treatment according to local standard of care (Käypä hoito 2010) should the cytological screening results (HSIL, ASC-H, AGC-FN) or three consecutive LSIL findings at repeated control visits within 3 years indicate it. The most common screening results (ASCUS, LSIL) are, however, not convened to arm A2 participants before age 28.
All cytology and HPV DNA results results are being revealed to all trial participants at age 28 at the study end.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Frequent information of screening results for cytology and/or HPV DNA at the ages of 25 (cytology only) and 28 (cytology only) vs A2 Receives: Other: Frequent information of cytological/ HPV DNA screening results |
| A2 | No intervention | infrequent information of cytological screening/ HPV DNA results, only at the age 28 years. |
| C | Active comparator | The third arm with at 8000 participants devoid of herd effect protection and frequent screening at ages 25 and 28 is enrolled for comparative analyses between A1 vs. C and A2 vs. C. Receives: Other: Frequent information of cytological/ HPV DNA screening results |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between arm A1 vs. arm C
No significant difference in the incidence ratios of CIN2/3 between arms A1 (participants under herd protection and frequently informed of the cytological results) vs. C (participants not under herd protection and frequently informed of the cytological findings) at the age of 28
Measured: Three years of follow up within 2020 - 2025
The difference between arm A2 vs. arm C
No significant difference in the incidence ratios of CIN2/3 between arms A2 (participants under herd protection and frequently informed of the cytological results) vs. C (participants not under herd protection and frequently informed of the cytological findings) at the age of 28.
Measured: Three years of follow up within 2020 - 2025
Secondary outcomes (3)
Quality of life in infrequently vs. frequently screened unvaccinated women (RAND 36)
The difference between infrequently and frequently screened unvaccinated women at the age of 28 is measured using RAND 36 to measure quality of life. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: Three years of follow up within 2021 - 2025
Quality of life in infrequently vs. frequently screened unvaccinated women (EQ-VAS)
The difference between infrequently and frequently screened unvaccinated women at the age of 28 is measured using EQ-VAS a vertical visual analogue scale on which patients provide a global assessment of their health. The scale takes values between 100 (best imaginable health) and 0 (worst imaginable health).
Measured: Three years of follow up within 2021 - 2025
Quality of life in infrequently vs. frequently screened unvaccinated women (CECA 10)
The difference between infrequently and frequently screened unvaccinated women at the age of 28 is measured using CECA 10, a Spanish acronym for the Specific Questionnaire for Condylomata Acuminata, summary scores of the emotional and sexual activity dimensions will be derived from CECA 10 scales. The CECA questionnaire includes 10 questions across 2 domains: emotional and sexual activity. CECA scores range from 0 (worst HRQL) to 100 (best HRQL)
Measured: Three years of follow up within 2021 - 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start9 Jun 2020
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- 14,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, European Union, Karolinska Institutet
- Responsible party
- Principal investigator, Tiina Eriksson, Tampere University Hospital
- Investigators
- Matti Lehtinen, MD, PhD, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755517
- Sponsor's protocol ID
- HPV400
- Acronym
- HPV400
- Status last verified
- Jan 2025
- First submitted
- 4 Feb 2021
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39450703Lehtinen 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, 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 35404177Gray 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 34097688Vanska 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 32161969
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cervical Screening in Unvaccinated, Herd Effect Protected Women - A Randomized Trial
- ClinicalTrials.gov ID
- NCT04755517
- Acronym / sponsor ID
- HPV400 / HPV400
- Keywords
- Cervical Intraepithelial Neoplasia, Neoplasms, Carcinoma in Situ, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Adenocarcinoma in situ
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, European Union, Karolinska Institutet
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Feb 2021 (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.
To identify: 1) Whether being informed infrequently results about screening is at least as a) safe and b) accurate as frequently obtaining all information from (the present combination of opportunistic/organized) cervical screening by comparing regimen results of two screening visits at the ages of 25 and 28 years (Arm A1) vs. results of one screening visit at the age of 28 years (Arm A2) in unvaccinated herd effect protected women. Unvaccinated, frequently screened women, who are not under herd effect protection will be controls (C).
Detailed description
Altogether 14.000 1995-1997 born women resident in communities where herd effect against high-risk HPV infections was created with gender-neutral vaccination of birth cohorts 1992-1995 (A-communities) or not (control C-communities) in 2007-2010 with the bi-valent HPV16/18 vaccine will be invited to participate a randomized screening trial at the ages of 25 and 28 years.
Cervical samples will be analysed for HPV DNA with MGP (Modified General Primer) primer system followed by MALDITOF(matrix assisted laser desorption ionization-time of flight mass spectrometry) mass spectrometry on the SEQUENOM (translation of genomic science into solutions for molecular medicine and biomedical research) platform (HPV).
With assumed 65% and 90% participation and retain rates the trial has 80% power to show non-inferiority of the infrequent vs. the frequent screening information.
At the study-end testing the null hypotheses of no difference in the incidence of the CIN2/3 (cervical squamous intraepithelial neoplasia 2/3) end-points comparing the A1 vs. C and A2 vs. C intervention arms will be done using the Mantel-Haenszel one degree of freedom chi-square statistics.
Work Content Letters of invitation to visit cervical screening at the nearest FICAN (Comprehensive Cancer Center Finland)-Mid study site will be send to the approximately 14.000 unvaccinated women at the ages of 25 and 28 years Following informed consent cervical liquid-based cytology samples will be taken for HPV DNA and/or cytology screening at study visits.
All cytological screening results will be communicated to Arm A1 and Arm C study participants. Arm A2 participants will get the test results at the age of 28. However, results of the cytology testing indicative of colposcopy according to local standard of care and currently accepted EU (the European Union) -guidelines (Käypä Hoito 2010, Franceschi et al. 2011) will be immediately communicated to all study participants. HPV DNA results will be communicated to all study participants at the study end. Pertinent colposcopy referrals to organized health care will be made.
All study participants will be offered a possibility to give an oropharyngeal sputum sample after 30 seconds gargling of sterile physiological saline (5 ml) for HPV PCR (polymerase chain reaction) analysis.
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: Frequent information of cytological/ HPV DNA screening resultsFrequent information of screening results for cytology and/or HPV DNA at the ages of 25 (cytology only) and 28 (cytology only) vs A2 |
| A2 | No intervention | –infrequent information of cytological screening/ HPV DNA results, only at the age 28 years. |
| C | Active comparator | Other: Frequent information of cytological/ HPV DNA screening resultsThe third arm with at 8000 participants devoid of herd effect protection and frequent screening at ages 25 and 28 is enrolled for comparative analyses between A1 vs. C and A2 vs. C. |
Who may qualify
- Ages
- 25 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Born 1995-1997. 25 years of age residence in one of the eight community-randomized trial A communities with documented herd effect from gender-neutral vaccination or C communities devoid of the herd effect.
Key exclusion criteria (1 listed)
- Immune compromising disease status (e.g. transplant recipients). HPV 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 |
|---|---|---|
| Frequent information of cytological/ HPV DNA screening resultsAll participants will be referred to pertinent diagnosis and treatment according to local standard of care (Käypä hoito 2010) should the cytological screening results (HSIL, ASC-H, AGC-FN) or three consecutive LSIL findings at repeated control visits within 3 years indicate it. The most common screening results (ASCUS, LSIL) are, however, not convened to arm A2 participants before age 28. All cytology and HPV DNA results results are being revealed to all trial participants at age 28 at the study end. | Other | A1, C |
Primary outcome
The difference between arm A1 vs. arm C
Time frame: Three years of follow up within 2020 - 2025
No significant difference in the incidence ratios of CIN2/3 between arms A1 (participants under herd protection and frequently informed of the cytological results) vs. C (participants not under herd protection and frequently informed of the cytological findings) at the age of 28
The difference between arm A2 vs. arm C
Time frame: Three years of follow up within 2020 - 2025
No significant difference in the incidence ratios of CIN2/3 between arms A2 (participants under herd protection and frequently informed of the cytological results) vs. C (participants not under herd protection and frequently informed of the cytological findings) at the age of 28.
3 secondary outcomes
Quality of life in infrequently vs. frequently screened unvaccinated women (RAND 36)
Time frame: Three years of follow up within 2021 - 2025
Quality of life in infrequently vs. frequently screened unvaccinated women (EQ-VAS)
Time frame: Three years of follow up within 2021 - 2025
Quality of life in infrequently vs. frequently screened unvaccinated women (CECA 10)
Time frame: Three years of follow up within 2021 - 2025
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 13 Jan 2025.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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.
Matti Lehtinen, MD, PhD principal investigator
Tampere University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequent information of cytological/ HPV DNA screening results in people with Cervical Intraepithelial Neoplasia Grade 2/3 and Adenocarcinoma in Situ, run by Tampere University Hospital at 18 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: enrolling by invitation, as of the sponsor's last update on 13 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 18 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?
The difference between arm A1 vs. arm C (time frame: Three years of follow up within 2020 - 2025). The study lists 2 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 NCT04755517, which also lists 5 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 13 Jan 2025.