Follow-up of Cell Changes in the Cervix

January 24, 2023 updated by: Joakim Dillner, Karolinska University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

885

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: HPV genotyping
HPV genotyping of samples classified that were positive for "other HPV"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cervical intraepithelial neoplasia 3 (CIN3+)
Time Frame: 2014-2018
Risk for developing CIN3+ or worse depending on HPV type
2014-2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Joakim Dillner, MD PhD, Joakim Dillner. Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 7, 2016

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (ACTUAL)

February 2, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data available through the Swedish National Cervical Screening Registry and on request from the PI.

IPD Sharing Time Frame

2016-2023

IPD Sharing Access Criteria

Ethical permission

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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