Follow-up of Cell Changes in the Cervix

Cancer of Cervix Clinical Trial

Official title:

Follow-up of Cell Changes in the Cervix

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05709730
• Other study ID #: AGC
• Status: Active, not recruiting
• Start date: July 7, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 885
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 80 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Cancer of Cervix
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• HPV genotyping
HPV genotyping of samples classified that were positive for "other HPV"

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cervical intraepithelial neoplasia 3 (CIN3+)	Risk for developing CIN3+ or worse depending on HPV type	2014-2018