Incidence of Cervical Cancer in HPV-positive Women With Low-grade Cytological Abnormalities
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gynaecologisch Oncologisch Centrum Zuid
- 入组人数
- 46,079
- 主要终点
- Five-year incidence cervical cancer
概览
简要总结
The goal of this observational study is to assess the five-year incidence of histologically confirmed cervical cancer among women who test positive for human papillomavirus (HPV) with low-grade cytological abnormalities, to evaluate whether follow-up intensity could be reduced in women participating in the Dutch population-based cervical cancer screening program who are HPV-positive and have low-grade cytological abnormalities - atypical squamous cells of undetermined significance (ASC-US), atypical glandular cells of endocervical origin (AGC), or low-grade squamous intraepithelial lesions (LSIL).
The main questions it aims to answer are:
What is the five-year risk of developing cervical cancer in HPV-positive women with low-grade cytological abnormalities?
Does the presence of subsequent low-grade cytology affect the five-year risk of cervical cancer in this population?
Researchers will compare the risk of cervical cancer in HPV-positive women with low-grade abnormalities to women with stable negative for intraepithelial lesion or malignancy (NILM) cytology, since women with stable NILM are discharged from further follow-up back to the screening programme. This will help evaluate whether follow-up intensity can be reduced in women with low-grade abnormalities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who participated in the cervical cancer screening program in the Netherlands between January 2017 and December 2018, who:
- •Tested HPV-positive with cytology results categorized as atypical squamous cells of undetermined significance (ASC-US), atypical glandular cells of endocervical origin (AGC), or low-grade squamous intraepithelial lesion (LSIL) according to the Bethesda system, or
- •Were HPV-positive and had stable negative for intra-epithelial leasion or malignancy (NILM) cytology after one year.
排除标准
- 未提供
结局指标
主要结局
Five-year incidence cervical cancer
时间窗: From enrollment up to 5 years after.
Incidence of histologically confirmed cervical cancer within the five-year screening interval.
次要结局
- Time to diagnosis of cervical carcinoma(From enrollment up to 5 years after.)
- All-cause mortality(From enrollment up to 5 years after.)
- Examination at which the diagnosis cervical carcinoma was established(Moment of diagnosis of cervical carcinoma from enrollment up to 5 years after.)
- Carcinoma subtype(Moment of diagnosis of cervical carcinoma within 5 years after enrollment.)
- Incidence of cervical cancer within 5 years of inclusion stratified by histological diagnosis within three months of enrollment(From enrollment up to 5 years after.)
研究者
Jurgen M.J. Piek
Principal investigator
Gynaecologisch Oncologisch Centrum Zuid