HairDx Analytical Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Determination of the precision and reproducibility of HairDx Test
研究概览
简要总结
The HairDx Test reports genetic variants associated with the development of FPHL.
详细描述
The HairDx Test reports genetic variants associated with the development of FPHL. The variants are detected from a saliva sample collected at home. The HairDx Test report is designed to help individuals understand the meaning of their results and encourage a conversation with a healthcare professional. The information provided by the HairDx Test report is not intended to start, stop or change any course of treatment. The purpose of this study is to collect DNA samples from subjects. The DNA samples will be used for the analytical validation of the HairDx Test. The results of this study will not be shared with the subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Females over the age of 18
- •Overall good health
- •Able to give informed consent
- •Willing to collect saliva sample
排除标准
- •Xerostomia (dry mouth)
- •Inability to provide informed consent in English
- •Inability to follow instructions for saliva sample collection
- •Non US resident
结局指标
主要结局
Determination of the precision and reproducibility of HairDx Test
时间窗: Baseline
Determination of the precision and reproducibility of HairDx Test in accordance with the laboratory instructions for use documentation
Determination of the accuracy of the HairDx Test
时间窗: Baseline
Determination of the accuracy of the HairDx Test in comparison to bi-directional Sanger sequencing
次要结局
未报告次要终点