Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Improved and Quality Assured Collection of First-void Urine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Human DNA (GAPDH)
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 1 (WP1): To accommodate for the detection of biomarkers in first-void urine, a next-generation first-void urine collection device is necessary, which includes internal process control, novel collector tubes for collection of smaller urine volumes, and integration of a non-toxic nucleic acid preservative.
Hereto, new generations of the Colli-Pee® (Novosanis) first-void urine collector allowing collection of smaller volumes (Colli-Pee Small Volumes 4 and 10 mL) next to the 'standard' Colli-Pee FV5000 (20 mL) first-void urine collector will be developed and validated. The optimal urine volume needed for detection of host and viral biomarkers, as well as optimization of the nucleic acid preservative solution by introduction of a sample/extraction validation control (non-human DNA internal control (DNA IC)) will be evaluated by measuring the concentration of human DNA, HPV DNA, and the DNA IC in all first-void urine samples using different DNA extraction protocols.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Women with a high-risk HPV positive test result within six months prior to study enrolment.
- •Giving informed consent to the research team to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
- •Able to understand the information brochure/what the study is about.
排除标准
- •Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.
- •Participating in another 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
Human DNA (GAPDH)
时间窗: Evaluation/testing when all samples are collected [1 year]
Comparison of human DNA (GAPDH) concentrations \[cycle threshold values\] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
Human DNA reference gene (ACTB)
时间窗: Evaluation/testing when all samples are collected [1 year]
Comparison of human DNA reference gene (ACTB) concentrations \[cycle threshold values\] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative methylation specific PCR (qMSP).
Internal control DNA (IC DNA)
时间窗: Evaluation/testing when all samples are collected [1 year]
Comparison of internal control DNA (IC DNA) concentrations \[cycle threshold values\] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
次要结局
- Human DNA (Beta-globin)(Evaluation/testing when all samples are collected [1 year])
- HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68))(Evaluation/testing when all samples are collected [1 year])
研究者
Pierre Van Damme
Principal Investigator
Universiteit Antwerpen