Human Papilloma VirusNCT05229679
HPV-based Screening Among Women 23-29 Years of Age
A study testing HPV testing in people with Human Papilloma Virus and Cervical Intraepithelial Neoplasia, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology. Read more about this study
- Who is it for?
- Ages 23 to 29 years, women only
- Conditions the study is for
- Human Papilloma Virus, Cervical Intraepithelial Neoplasia, Cervical Cancer
- What is being tested?
- HPV testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180,000 participants
- Where
- 2 sitesSweden
- Study dates
- 16 Nov 2020to 31 Dec 2038
- 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 23 to 29 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women ages 23-29 invited to screening.
Who cannot join
- Women who do not show up for screening or do not consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 1 recruiting
- Active, not recruiting
Region of Skåne
Lund, Skåne County, 221 00
- Recruiting
Region Stockholm
Stockholm, 102 39
Joakim Dillner, MD, PhD, +46 (0) 72-468 24 60, joakim.dillner@ki.se
About this study
Official title: Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women
The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology.
Read the detailed description
The aim is to investigate whether primary HPV analysis in the organized cell sampling program for women in the age group 23-29 provides higher cancer protection compared to the current method where cell samples are primarily analyzed with cytology. In this study, all women in the age group 23-29 in the Stockholm and Skåne Region of Sweden will participate. Age is defined by year of birth. For 2020, women born 1991-1997 are included. Sampling and collection of samples is the same as for cytology.
- Being tested
- HPV testing
- Keywords
- Organized screening, HPV vaccination, Human papilloma virus, Prevention
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV testingDiagnostic test
All women age 23-29 resident in the pilot counties will be invited to HPV screening as of the study start date. The same invitation as currently used for women aged 30 and upwards will be used. This information clearly states that it is possible to opt out of the program and that data from the screening program will be collected to regional and national quality registers who will systematically evaluate the quality of the care. At the screening station, the samples are collected identically regardless of primary screening test used - there is no change in the procedures used neither for the woman or for the midwives taking the sample. HPV testing will be performed using the same purchased, CE-marked and accredited HPV screening platforms as currently used for women aged 30 and upwards. The cytology is according to the liquid-based cytology method.
| Study group | Role | What they receive |
|---|---|---|
| HPV-based screening | Experimental | Women 23-29 invited to cervical screening will have their samples analyzed for HPV. Receives: Diagnostic Test: HPV testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured: Measured once during 1 year, year 1.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured: Measured once during 1 year, year 2.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured: Measured once during 1 year, year 3.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured: Measured once during 1 year, year 4.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured: Measured once during 1 year, year 5.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured: Measured once during 1 year, year 6.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured: Measured once during 1 year, year 7.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured: Measured once during 1 year, year 8.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured: Measured once during 1 year, year 9.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured: Measured once during 1 year, year 10.
Secondary outcomes (10)
Cost-effectiveness of the new screening method
Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.
Measured: Measured once during 1 year, year 1.
Cost-effectiveness of the new screening method
Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.
Measured: Measured once during 1 year, year 2.
Cost-effectiveness of the new screening method
Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.
Measured: Measured once during 1 year, year 3.
Cost-effectiveness of the new screening method
Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.
Measured: Measured once during 1 year, year 4.
Cost-effectiveness of the new screening method
Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.
Measured: Measured once during 1 year, year 5.
Cost-effectiveness of the new screening method
Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.
Measured: Measured once during 1 year, year 6.
Cost-effectiveness of the new screening method
Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.
Measured: Measured once during 1 year, year 7.
Cost-effectiveness of the new screening method
Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.
Measured: Measured once during 1 year, year 8.
Cost-effectiveness of the new screening method
Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.
Measured: Measured once during 1 year, year 9.
Cost-effectiveness of the new screening method
Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.
Measured: Measured once during 1 year, year 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start16 Nov 2020
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joakim Dillner, Karolinska Institutet
- Investigators
- Joakim Dillner, MD, PhD, Principal investigator, Karolinska University Hospital/Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229679
- Sponsor's protocol ID
- 2020-00053
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2021
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD has been discussed but a plan isn't finalized.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women
- ClinicalTrials.gov ID
- NCT05229679
- Acronym / sponsor ID
- 2020-00053
- Keywords
- Organized screening, HPV vaccination, Human papilloma virus, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 31 Dec 2038 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 8 Feb 2022 (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.
The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology.
Detailed description
The aim is to investigate whether primary HPV analysis in the organized cell sampling program for women in the age group 23-29 provides higher cancer protection compared to the current method where cell samples are primarily analyzed with cytology. In this study, all women in the age group 23-29 in the Stockholm and Skåne Region of Sweden will participate. Age is defined by year of birth. For 2020, women born 1991-1997 are included. Sampling and collection of samples is the same as for cytology.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV-based screening | Experimental | Diagnostic Test: HPV testingWomen 23-29 invited to cervical screening will have their samples analyzed for HPV. |
Who may qualify
- Ages
- 23 to 29 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women ages 23-29 invited to screening.
Key exclusion criteria (1 listed)
- Women who do not show up for screening or do not consent.
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 |
|---|---|---|
| HPV testingAll women age 23-29 resident in the pilot counties will be invited to HPV screening as of the study start date. The same invitation as currently used for women aged 30 and upwards will be used. This information clearly states that it is possible to opt out of the program and that data from the screening program will be collected to regional and national quality registers who will systematically evaluate the quality of the care. At the screening station, the samples are collected identically regardless of primary screening test used - there is no change in the procedures used neither for the woman or for the midwives taking the sample. HPV testing will be performed using the same purchased, CE-marked and accredited HPV screening platforms as currently used for women aged 30 and upwards. The cytology is according to the liquid-based cytology method. | Diagnostic test | HPV-based screening |
Primary outcome
Incidence of cervical cancer
Time frame: Measured once during 1 year, year 1.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time frame: Measured once during 1 year, year 2.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time frame: Measured once during 1 year, year 3.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time frame: Measured once during 1 year, year 4.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time frame: Measured once during 1 year, year 5.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time frame: Measured once during 1 year, year 6.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time frame: Measured once during 1 year, year 7.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time frame: Measured once during 1 year, year 8.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time frame: Measured once during 1 year, year 9.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time frame: Measured once during 1 year, year 10.
Cervical cancer incidence in the intervention group compared to a historical control group.
10 secondary outcomes
Cost-effectiveness of the new screening method
Time frame: Measured once during 1 year, year 1.
Cost-effectiveness of the new screening method
Time frame: Measured once during 1 year, year 2.
Cost-effectiveness of the new screening method
Time frame: Measured once during 1 year, year 3.
Cost-effectiveness of the new screening method
Time frame: Measured once during 1 year, year 4.
Cost-effectiveness of the new screening method
Time frame: Measured once during 1 year, year 5.
Cost-effectiveness of the new screening method
Time frame: Measured once during 1 year, year 6.
Cost-effectiveness of the new screening method
Time frame: Measured once during 1 year, year 7.
Cost-effectiveness of the new screening method
Time frame: Measured once during 1 year, year 8.
Cost-effectiveness of the new screening method
Time frame: Measured once during 1 year, year 9.
Cost-effectiveness of the new screening method
Time frame: Measured once during 1 year, year 10.
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 19 Mar 2025.
- Individual participant dataSharing planned: Undecided. IPD has been discussed but a plan isn't finalized.
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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.
Joakim Dillner, MD, PhD principal investigator
Karolinska University Hospital/Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV testing in people with Human Papilloma Virus and Cervical Intraepithelial Neoplasia, run by Karolinska Institutet at 2 sites in Sweden.
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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Contact Joakim Dillner, MD, PhD (+46 (0) 72-468 24 60, joakim.dillner@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cervical cancer (time frame: Measured once during 1 year, year 1.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2025.