Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Validation for Detection of Precursor Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 6
- 主要终点
- HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) measured using the HPV-risk assay (Self-Screen BV).
研究概览
简要总结
The goal of the overall CASUS project is to develop the first fully molecular integrated cervical cancer screening approach, based on first-void urine as an easily accessible and non-invasive source of biomarkers. In contrast to current screening modalities, the CASUS approach will identify women with clinically relevant disease in need of treatment using only a single sample that can be collected at home (one-step triage).
详细描述
CASUS work package 4 (WP4):
The main aim of this study is to validate the HPV-Risk assay (Self-screen, The Netherlands) followed by multiplex methylation specific quantitative PCR (qMSP, VU University Medical Center, The Netherlands) on first-void urine (Colli-Pee Small Volumes (10 mL) device, Novosanis, Belgium) of HPV positive women for detection of clinically relevant precursor lesions by sampling a cohort of women referred for colposcopy. The number of women in this cohort will allow us to clinically validate the use of the HPV-Risk/qMSP assay in DNA extracts of first-void samples after optimization of sample volume, internal process control, and DNA extraction method (Centre for the Evaluation of Vaccination, University of Antwerp, Belgium).
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
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •25 years until 64 years old
- •Referred to colposcopy due to a single/multiple (probable) high-risk HPV infection and/or abnormal cervical squamous intraepithelial/glandular lesion.
- •Gives informed consent to the research team at the clinical study site to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
- •Is able to understand the information brochure/what the study is about.
排除标准
- •Women that underwent hysterectomy
- •Pregnant women
- •Treatment for cervical cancer in the last 6 months before participation in the study
- •Participating in an interventional clinical study (where e.g. a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.
结局指标
主要结局
HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) measured using the HPV-risk assay (Self-Screen BV).
时间窗: Through study completion, an average of 1 year
Analytical test results: HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) concentrations \[cycle threshold values\] in first-void urine samples from all study participants. Clinical test accuracy: HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) test outcomes \[positive, negative\] in first-void urine samples from all study participants compared to the gold standard reference test for cervical cancer screening; i.e. histology \[Cervical Intraepithelial Neoplasia grade 0-3+\].
Methylation ratio of a host cell gene marker panel (PreCursor-U+) measured using quantitative methylation specific PCR (qMSP).
时间窗: Through study completion, an average of 1 year
Analytical test results: Methylation levels of a host cell gene marker panel (PreCursor-U+) reported in a methylation ratio \[(2\^-deltaCT \*100) with CT being cycle threshold values\] in first-void urine samples from all study participants. Clinical test accuracy: Methylation panel (PreCursor-U+) test outcomes \[positive, negative\] in first-void urine samples from all study participants compared to the gold standard reference test for cervical cancer screening; i.e. histology \[Cervical Intraepithelial Neoplasia grade 0-3+\].
次要结局
- Human DNA (GAPDH)(Through study completion, an average of 1 year)
- Internal control DNA (IC DNA)(Through study completion, an average of 1 year)
- Human DNA (Beta-globin)(Through study completion, an average of 1 year)
- Human DNA reference gene (ACTB)(Through study completion, an average of 1 year)
研究者
Pierre Van Damme
Principal Investigator
Universiteit Antwerpen