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Follow-up of Cell Changes in the Cervix

Follow-up of Cell Changes in the Cervix

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05709730
Enrollment
885
Registered
2023-02-02
Start date
2016-07-07
Completion date
2029-12-01
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Cervix

Brief summary

The purpose of the study is to follow up on cell changes detected in the cervical cancer screening program, to investigate whether they are handled with adequate quality.

Detailed description

The aim of the study is to clarify whether follow-up of cell changes is carried out with sufficiently good quality. It is nationally recommended to perform an HPV test on mild cell changes and only refer to clinical follow-up if you are HPV positive. Descriptive statistics on HPV-testing and follow-up of quality are not available today. If HPV testing has not already been performed, archived samples with glandular cell changes will be HPV-analyzed in Cobas 4800 HPV-polymerase chain reaction (PCR), which shows data on the presence of HPV and Luminex-PCR, which shows which HPV types the samples have. Women with low-grade squamous cell changes (ASCUS and CIN1) with simultaneous HPV analysis will be followed up with data from the Swedish National Cervical Screening Registry (NKCx) from the last ten years. A register linkage with data from NKCx and the National Cancer Registry at the National Board of Health and Welfare will be carried out to determine which women have developed gynecological cancer, cervical cancer and/or pre-cancer (cancer in situ). A follow-up review of reported original cytological (cell samples) and histological (tissue samples) diagnoses will be performed by cytodiagnostics and cytopathologists, to verify the correct diagnosis. Statistics on collection of non-organized cell samples after a partial negative sample where follow-up is not recommended are produced in aggregated form in the form of an extract from NKCx

Interventions

DIAGNOSTIC_TESTHPV genotyping

HPV genotyping of samples classified that were positive for other HPV

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
23 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* women with an AGC diagnosis between February 17, 2014 and December 31, 2018 * 23-80 years old * resident of the Stockholm-Gotland region of Sweden

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
cervical intraepithelial neoplasia 3 (CIN3+)2014-2018Risk for developing CIN3+ or worse depending on HPV type

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026