NCT07850128

Brief 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. 1.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?
  2. 2.How risky a persistent HPV detection is, and whether persistent detection of any high-risk HPV genotype warrant immediate clinical assessment?
  3. 3.How risky a HPV detection is, if no previous HPV test result is available?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130,000

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2025Dec 2026

Study Start

First participant enrolled

October 31, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

3 days

First QC Date

September 24, 2026

Last Update Submit

September 24, 2026

Conditions

Cervical Cancer ScreeningHPV Infection

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of invasive cervical cancer

    Primary and invasive cervical cancer

    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)

    From HPV infection to the end of the study Dec 31st, 2024

Study Arms (3)

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

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

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

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational CohortOTHER

All data will be retrieved retrospectively from registry data.

History-unknown HPV detectionIncident HPV detectionPersistent HPV detection

Eligibility Criteria

Age22 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • Women without valid personal identity number in the population registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Cervical Cancer Elimination, Department of Clinical Science, Intervention and Technology, Karolinska Institutet

Stockholm, 141 52, Sweden

RECRUITING

Related Publications (2)

  • 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.

    PMID: 39921417RESULT

  • Wei 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.

    PMID: 39097395RESULT

Related Links

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jiangrong Wang, PhD

CONTACT

+46769309451jiangrong.wang@ki.se

Joakim Dillner, PhD

CONTACT

joakim.dillner@ki.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 24, 2026

First Posted

September 30, 2026

Study Start

October 31, 2025

Primary Completion

November 3, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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.

Locations

SE(1)