Cervical Cancer ScreeningNCT07850128
Risk of Cervical Cancer Following Incident, Persistent and History-unknown HPV Detection
An observational study of Cervical Cancer Screening and HPV Infection, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The goal of this register-based retrospective observational study is to understand the risk of cervical cancer following incident, persistent and history-unknown HPV detection by HPV genotype in healthy women participating in HPV-based cervical screening. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 22 to 70 years, women only
- Conditions the study is for
- Cervical Cancer Screening, HPV Infection
- How many people
- 130,000 participants
- Where
- 1 siteSweden
- Study dates
- 31 Oct 2025to Dec 2026
- Phase
- Observational
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women living in the Great Stockholm Region in Sweden, at cervical screening ages (age 22-70 years), and having had an HPV positive result in the primary HPV test during 2014-2023
Who may be able to join
- Women living in the Great Stockholm Region in Sweden, at cervical screening ages (age 22-70 years), and having had an HPV positive result in primary HPV test during 2014-2023
Who cannot join
- Women without valid personal identity number in the population registry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joakim Dillner, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Centre for Cervical Cancer Elimination, Department of Clinical Science, Intervention and Technology, Karolinska Institutet
Stockholm, 141 52
Jiangrong Wang, PhD, +46769309451, jiangrong.wang@ki.se
jiangrong.wang@ki.se
About this study
Official title: Risk of Cervical Cancer Following Incident, Persistent and History-unknown Human Papillomavirus (HPV) Detection by HPV Genotype
The goal of this register-based retrospective observational study is to understand the risk of cervical cancer following incident, persistent and history-unknown HPV detection by HPV genotype in healthy women participating in HPV-based cervical screening. The main questions it aims to answer are:
- Whether an incident HPV detection with certain HPV genotypes has low risk of cervical cancer in 3 to 5 years thus does not need further clinical assessment before the next screening test?
- How risky a persistent HPV detection is, and whether persistent detection of any high-risk HPV genotype warrant immediate clinical assessment?
- How risky a HPV detection is, if no previous HPV test result is available?
As being a register-based retrospective observational study, study subjects will not be asked to do any specific task for this study.
Read the detailed description
This study includes all women in the study population (women at screening ages and living in the Stockholm region during 2014-2023) who had HPV positive test result(s) in the primary HPV screening. In 2014-2016, half of the screening population were randomised to primary HPV screening and the other half received cytology-based screening (NCT01511328). From 2017 onwards, all women received primary HPV screening. As data are retrieved from established registries which are already accessible to the researchers for previous and ongoing related research projects, the data collection time is almost negligible.
- Conditions
- Cervical Cancer Screening, HPV Infection
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
All data will be retrieved retrospectively from registry data.
| Study group | Role | What they receive |
|---|---|---|
| Incident HPV detection | The first HPV positive result in the primary HPV test, following an HPV negative test result in the previous primary HPV test Receives: Other: No Intervention: Observational Cohort | |
| Persistent HPV detection | The HPV positive result in the primary HPV test following an HPV positive test result with the same genotype in the previous primary HPV test Receives: Other: No Intervention: Observational Cohort | |
| History-unknown HPV detection | The first HPV positive result in the primary HPV test, without any primary HPV test record in the past Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of invasive cervical cancer
Primary and invasive cervical cancer
Measured: From HPV infection to the end of the study Dec 31st, 2024
Secondary outcomes (1)
Precancerous lesion CIN2+ (Cervical Intraepithelial Neoplasia grade 2 and above)
CIN2, CIN3, Adenocarcinoma in situ
Measured: From HPV infection to the end of the study Dec 31st, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start31 Oct 2025
- Primary completion3 Nov 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Cancer ScreeningStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiangrong Wang, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850128
- Sponsor's protocol ID
- IPUHPV&CxCa
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Individual data sharing
- Yes: IPD will be derived from the Swedish National Cervical Screening Registry and the Swedish National Quality Register for Gynaecological Cancers. Data from these two registries can be shared upon application, provided that ethical approval is obtained.
Publications
Bjorge T, Stoer NC, Hverven SK, Nygard M, Trope A, Engesaeter B. Risk of high-grade cervical lesions in the second round of primary human papillomavirus testing in CervicalScreen Norway: A population-based cohort study. Int J Cancer. 2025 Jul 15;157(2):251-259. doi: 10.1002/ijc.35359. Epub 2025 Feb 8.
PubMed 39921417Wei F, Georges D, Man I, Baussano I, Clifford GM. Causal attribution of human papillomavirus genotypes to invasive cervical cancer worldwide: a systematic analysis of the global literature. Lancet. 2024 Aug 3;404(10451):435-444. doi: 10.1016/S0140-6736(24)01097-3.
PubMed 39097395