Clinical trial NCT05709730: Follow-up of Cell Changes in the Cervix
Official title: Follow-up of Cell Changes in the Cervix
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer of Cervix
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 885
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women aged 23 years and older, residing in the Stockholm-Gotland region of Sweden who had an AGC diagnosis in a cervical cytology sample between February 17th, 2014, and December 31st, 2018. For eligibility, an HPV test result and a subsequent histopathological diagnosis is also required. HPV testing performed 40 days before or after the index sampling date is considered to indicate the HPV status of the index AGC.

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

Eligibility criteria: 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:

-

Primary outcomes:
measure: cervical intraepithelial neoplasia 3 (CIN3+)
timeFrame: 2014-2018
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Joakim Dillner. Professor
name: Joakim Dillner, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norman I, Yilmaz E, Hjerpe A, Hortlund M, Elfstrom KM, Dillner J. Atypical glandular cells and development of cervical cancer: Population-based cohort study. Int J Cancer. 2022 Dec 1;151(11):2012-2019. doi: 10.1002/ijc.34242. Epub 2022 Aug 27.