Analytical Validation of Circulating DNA Analysis Methods: Creation of a Control Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Proportion of participants for which no pathogenic mutation has been detected on the MSK-Access panel.
研究概览
简要总结
Pilot, prospective, mono-center study conducted in a population of healthy participants (free of cancer) for the analytical validation of circulating DNA analysis methods. The participants are employees of the institution. Their recruitement is carried out via internal posting (intranet and bulletin boards). The study participation will be strictly voluntary and without consequences on the professional situation of the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •1 Adult volunteer (≥ 18 y.o.)
- •2 Participant free of cancer
- •3 Participant belonging to the personnel of Oncopole Claudius Regaud (IUCT-O) institution
- •4 Participant affiliated to a Social Health Insurance in France
- •5 Participant who received clear and understandable information about the research
- •6 Participant who signed an informed consent form before inclusion into the study and before any study specific procedure
- •7 Participant who accepts a blood draw in the context of the research
- •8 Participant who agrees to be contacted in the event of an incidental finding of a potential genetic abnormality
排除标准
- •1 Participant presenting with an associated pathology potentially preventing the adequate conduct of the study procedure
- •2 Participant presenting with a contra-indication to blood draw
- •3 Participant who reports to the investigator team
- •4 Participant who has forfeited his/her freedom bu administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
研究组 & 干预措施
Blood draw for analysis
干预措施: 1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL). (Diagnostic Test)
结局指标
主要结局
Proportion of participants for which no pathogenic mutation has been detected on the MSK-Access panel.
时间窗: baseline
Ratio of number of participants without pathogenic mutation on the MSK-Access panel over the total number of participants
次要结局
- Proportion of participants for wich no pathogenic mutation has been detected on the HRR-Liq panel(baseline)
- Proportion of participants for wich no pathogenic mutation has been detected on by digital PCR(baseline)
- Analytical specificity of the estimation of the circulating tumoral fraction: Proportion of participants for which the circulating tumoral fraction is inferior to the detectability threshold(baseline)
- Analytical specificity of the measurement of circulating DNA fragments' size via electrophoresis: Proportion of participants with an absence of DNA fragments of a size inferior to 150 pb(baseline)