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临床试验/NCT05709730
NCT05709730进行中(未招募)不适用

Follow-up of Cell Changes in the Cervix

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 885 人开始时间: 2016年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
885
试验地点
1
主要终点
cervical intraepithelial neoplasia 3 (CIN3+)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
23 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

cervical intraepithelial neoplasia 3 (CIN3+)

时间窗: 2014-2018

Risk for developing CIN3+ or worse depending on HPV type

次要结局

未报告次要终点

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joakim Dillner

Professor

Karolinska University Hospital

研究点 (1)

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