SElf-SAMpling in Cervical Cancer Screening. SESAM Study; a Key to Better Health. Clinical Validation of a Self-sampling Device in Patients With Cervical Cancer and Cervical Pre-invasive Neoplasia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 310
- 试验地点
- 4
- 主要终点
- High-risk HPV (hrHPV) testing on self-sampled specimens has non-inferior sensitivity for CIN 2+ compared to clinician-sampled specimens.
研究概览
简要总结
Study aims to support development of evidence based health care in Norway through evaluating recently proposed technological improvements in cervical cancer control before their routine use. SESAM II study evaluates the accuracy of vaginal self-sampling for high risk human papillomavirus (hrHPV) testing compared with a physician-taken sample.
详细描述
Concept of collecting cervical cancer screening smear in home through self-sampling is new both for target population and medical professionals. Self-sampling increases screening attendance and could be an alternative to recruit more women to cervical cancer screening in Norway. As there are is an implementation ongoing to switch from cytology based screening to HPV based screening in Norway, a reliable self-sampling method for HPV testing should be available. Furthermore, detection of HPV from self-sampled specimen requires laboratory capacity and expertise to comply with quality assurance demands such as internal quality control, external quality assessment and quality improvement. National studies are crucial to obtain knowledge and build expertize among health care providers. This study aims to show non-inferior sensitivity of hrHPV testing on self-sampled vs. clinician-sampled specimens to detect high-grade cervical lesions and cancer (CIN2+). Additionally we will;
- Evaluate overall and hrHPV type specific concordance between self-taken and physician-taken samples.
- Evaluate participants views on feasibility and acceptability of self-sampling (questionnaire)
- Compare participants screening history with the questionnaire to evaluate the reason for not participating in the national screening program (if that is the case).
- Biobank biological material collected from self-sample, physician taken samples, blood and urine, for future analysis on HPV-related diseases and cancer.
Study participants will be recruited from the colposcopy referrals and cancer care units from three different hospitals. Patients with CIN 2 or CIN 3 lesions (n=200) will be recruited from Oslo University Hospital, Ullevål and Østfold Hospital Trust, while cancer patients (n=50) will be recruited from Radiumhospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histological verified CIN 2 or CIN 3
- •Women with histological verified cervical cancer
排除标准
- •Women with mild cervical lesions
研究组 & 干预措施
Study group
Each women recruited for the study belong to the study group. Intervention is performance of HPV testing on Evalyn®Brush and FloqSwab specimens compared to clinician-sampled specimen. Providing an urinary sample (Colli-PeeTM), blood, and a questionnaire data is optional.
干预措施: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens (Device)
结局指标
主要结局
High-risk HPV (hrHPV) testing on self-sampled specimens has non-inferior sensitivity for CIN 2+ compared to clinician-sampled specimens.
时间窗: Sensitivity will be assessed through study completion, up to 36 months
Relative sensitivity will be measured through histologically confirmed detection rates using clinician-sampled specimen as a reference.
次要结局
- Overall and hrHPV specific concordance between self- and clinician-sampled specimens(Through study completion, an average of 6 months)
- Participants screening history and reasons for possible non-participation(Through study completion, an average of 6 months)
- Acceptability of feasibility of self-sampling(Through study completion, an average of 6 months)
研究者
Mari Nygård
Senior Medical Officer, Head of HPV-related Epiemiological Research Unit
Oslo University Hospital