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临床试验/NCT02797743
NCT02797743Unknown不适用

Whole Blood Specimen Collection From Healthy Subjects

Progenity, Inc.3 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
750
试验地点
3
主要终点
Whole blood collection

研究概览

简要总结

This study will obtain whole blood specimens from healthy subjects to be used for research and development and clinical validation of genetic assays.

详细描述

Progenity is developing diagnostic products to improve the healthcare of men, women, and children. The commercial objective is to make safe, noninvasive genetic testing available to the public, independent of age and other factors that may contribute to pregnancy or other clinical complications.

Sample specimens will not be used to develop genetic lines and/or DNA banks for cloning. Any samples or remnant specimens remaining may be stored indefinitely for future research programs.

Eligible subjects (or parent/guardian) will provide written informed consent after which basic demographic and clinical data will be obtained and a whole blood sample will be collected. A subject's participation may end immediately after their blood draw. The amount of whole blood drawn at any visit will be based upon age of the subject and test to be performed.

In the event a Subject is pregnant, information regarding the gender of the fetus established by either ultrasound, non-invasive prenatal testing (NIPT) results, or at delivery will be collected. Clinical data regarding any karyotyping procedure that may occur on the fetus will be recorded.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Subject (or guardian)is willing to provide written informed consent to have up to 50 mL of whole blood collected at a single clinic visit (maximum blood volume will depend on age of subject)
  • Subject is considered healthy (and if pregnant, their pregnancy is progressing normally)
  • If pregnant, Subject is carrying a singleton fetus of 10 to 26 weeks' gestational age inclusive

排除标准

  • Women who are not pregnant
  • If pregnant, pregnancy is non-viable
  • If pregnant, evidence of or suspected fetal anomaly based on ultrasound finding, abnormal 1st trimester screening or abnormal NIPT
  • Immediate family history of a previous fetal aneuploidy

结局指标

主要结局

Whole blood collection

时间窗: about 3 years

Whole blood collection from 750 healthy subjects total

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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