Feasibility Study Aiming at Pre-Analytical Standardization of Whole Blood Processing for Liquid Biopsy Applications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- cfDNA quality control
研究概览
简要总结
The goal of this feasibility study is to evaluate a new sample preparator called See.d.
After blood processing the instrument will produce a set of slides and a tube of plasma. These outputs could be used in further analysis in liquid biopsy applications.
详细描述
This feasibility study aims at the evaluation of a new instrument called See.d , to be used in conjunction with its accessories, Smart Bio Surface (SBS) slides and reagents, for preparation of cytological samples (seeded on SBS slides) and plasma from fresh whole blood (within 4-6 hours from collection).
Blood samples will be collected from healthy volunteers and will be used to test See.d performances. Moreover the possibility of develop a new version of the instrument with increased processing capability and to develop and optimize analytical protocols for liquid biopsy applications will be evaluated as exploratory objectives.
The only study procedure will be the collection of a blood sample from each participants; during this study 200 participants will be enrolled.
For its feasibility nature, no formal statistics has been planned for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are willing and able to give and sign a written informed consent
- •Aged 18 or above
排除标准
- •Ongoing infections requiring antibiotic or antiviral treatment
- •Known hemostasis/coagulation disorder
- •Known Pregnancy
研究组 & 干预措施
Healthy donors
Participants who are in good health and willing to provide a blood sample
结局指标
主要结局
cfDNA quality control
时间窗: 1 day (at the blood draw)
Evaluation of the ratio between cfDNA and genomic contaminant DNA
Feasibility of staining on slides produced by See.d
时间窗: 1 day (at the blood draw)
Qualitative assessment of staining positivity
Feasibility of using See.d SBS slides for subsequent analysis
时间窗: 1 day (at the blood draw)
Recovery of mock-Circulating Tumor Cells (CTCs)
SBS slides stability
时间窗: 1 day (at the blood draw)
Evaluation of the area of adhered cell nuclei on SBS slides
Reagents stability
时间窗: 1 day (at the blood draw)
Evaluation of total adhered cell count on SBS slides
Feasibility of using See.d plasma for subsequent analysis
时间窗: 1 day (at the blood draw)
Recovery of spiked reference DNA
次要结局
未报告次要终点