Follow-up of Cell Changes in the Cervix

NCT ID: NCT05709730

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

885 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-07

Study Completion Date

2029-12-01

Brief Summary

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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

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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

Conditions

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Cancer of Cervix

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Women aged 26-80 with atypical glandular cell (AGC) cytology result

Women in the capital region of Sweden with AGC, a concomitant human papillomavirus (HPV) analysis, and a histopathology.

HPV genotyping

Intervention Type DIAGNOSTIC_TEST

HPV genotyping of samples classified that were positive for "other HPV"

Interventions

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HPV genotyping

HPV genotyping of samples classified that were positive for "other HPV"

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

\-
Minimum Eligible Age

23 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joakim Dillner

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joakim Dillner, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Joakim Dillner. Professor

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 36029205 (View on PubMed)

Other Identifiers

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AGC

Identifier Type: -

Identifier Source: org_study_id

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