Risk of Cervical Cancer Following Incident, Persistent and History-unknown HPV Detection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age22-70
SponsorKarolinska Institutet
About this trial
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. 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. How risky a persistent HPV detection is, and whether persistent detection of any high-risk HPV genotype warrant immediate clinical assessment? 3. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Women without valid personal identity number in the population registry
Trial 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
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionAll data will be retrieved retrospectively from registry data.
Treatment groups
130,000 Participants
are divided into 3 treatment groupsGroup A: Incident HPV detection1 intervention
Group B: Persistent HPV detection1 intervention
Group C: History-unknown HPV detection1 intervention
Trial outcomes
Primary outcomes
1
Diagnosis of invasive cervical cancer
Primary and invasive cervical cancer
Time frame
From HPV infection to the end of the study Dec 31st, 2024Secondary outcomes
1
Precancerous lesion CIN2+ (Cervical Intraepithelial Neoplasia grade 2 and above)
CIN2, CIN3, Adenocarcinoma in situ
Time frame
From HPV infection to the end of the study Dec 31st, 2024Sponsors and contacts
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Source ClinicalTrials.gov