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Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers

2022年4月22日更新者：Illumina, Inc.

Prospective Collection of Whole Blood Specimens of Subjects Diagnosed With Preeclampsia With Severe Features and/or Fetal Growth Restriction in Support of a Molecular Assay Development

Sample Collection Study

研究概览

地位

完全的

条件

先兆子痫

详细说明

This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction in addition to samples from a control group to aid in the development of a Next Generation Sequencing (NGS)-based assay to detect molecular markers associated with preterm preeclampsia.

研究类型

观察性的

注册 (实际的)

242

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Delaware
  - Newark、Delaware、美国、19718
    - Christiana Hospital
- Massachusetts
  - Boston、Massachusetts、美国、02111
    - Tufts Medical Center
- New Jersey
  - New Brunswick、New Jersey、美国、08901
    - Saint Peter's University Hospital
  - Piscataway、New Jersey、美国、08854
    - Rutgers University
  - Sewell、New Jersey、美国、08080
    - Virtua Materna-Fetal Medicine Specialists
- New York
  - Flushing、New York、美国、11355
    - New York-Presbyterian/Queens
  - New York、New York、美国、10032
    - New York-Presbyterian/Columbia University Medical Center
  - New York、New York、美国、11501
    - Winthrop University Hospital Clinical Trials Center
- Pennsylvania
  - Philadelphia、Pennsylvania、美国、19102
    - Drexel Medicine
- Texas
  - Galveston、Texas、美国、77555
    - The University of Texas Medical Branch

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Affected Group: Pregnant women diagnosed with preeclampsia with severe features or fetal growth restriction

Control group: Pregnant women matched for gestational age to the Affected group above

描述

Inclusion Criteria:

Women 18 years of age or older at enrollment
Pregnant women with a viable singleton gestation
Able to provide written, informed consent
Able to provide 20 mL of whole blood
Diagnosis of preeclampsia with severe features and/or diagnosis of fetal growth restriction.
1. Preeclampsia with severe features is defined as:
  Proteinuria: Excretion of ≥300mg/24hr (24 hour collection) of protein or a timed excretion that is extrapolated to the 24 hour urine value or a protein/creatinine [both in mg/dL] ratio of at least 0.3 or a qualitative determination of (urine dipstick) of ≥1+ WITH Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on at least 2 occasions 4 hours apart while on bedrest but before the onset of labor OR Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on 1 occasion but before the onset of labor, if antihypertensive therapy is initiated due to severe hypertension OR New onset hypertension defined as: Systolic BP ≥140 mmHg or diastolic ≥90 mmHg with one or more of the following features: Thrombocytopenia (<100,000 plts/mL); impaired liver function (AST/ALT 2X ULN); newly developed renal insufficiency (serum creatinine >1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease); pulmonary edema; new onset cerebral disturbances or scotomata
2. Fetal Growth Restriction defined as:
Estimated fetal weight by ultrasound at ≥ 19 0/7 weeks gestational age < 5%ile or 5-10%ile with abnormal umbilical artery Doppler examination (S/D ratio >95%ile for gestational age, absent end diastolic flow or reverse end diastolic flow)
Gestational age between 20 0/7 and 33 6/7 weeks determined by ultrasound and/or LMP per ACOG guidelines1. A subject diagnosed with preeclampsia without severe features prior to 33 6/7 weeks gestation and who is managed expectantly and develops severe features after 34 weeks may be included.

Exclusion Criteria:

Known malignancy
History of maternal organ or bone marrow transplant
Maternal blood transfusion in the last 8 weeks
Chronic hypertension diagnosed prior to current pregnancy
Type I, II or gestational diabetes
Fetal anomaly or known chromosome abnormality
Active labor

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Affected Group Women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction.
Control/Unaffected Group Women who do not have a diagnosis of preeclampsia with severe features and/or fetal growth restriction.

研究衡量的是什么？

主要结果指标

结果测量	大体时间
cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions 大体时间：2 years	2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Illumina, Inc.

调查人员

研究主任：Matthew Rhoa, MD、Illumina, Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Munchel S, Rohrback S, Randise-Hinchliff C, Kinnings S, Deshmukh S, Alla N, Tan C, Kia A, Greene G, Leety L, Rhoa M, Yeats S, Saul M, Chou J, Bianco K, O'Shea K, Bujold E, Norwitz E, Wapner R, Saade G, Kaper F. Circulating transcripts in maternal blood reflect a molecular signature of early-onset preeclampsia. Sci Transl Med. 2020 Jul 1;12(550):eaaz0131. doi: 10.1126/scitranslmed.aaz0131.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年3月1日

初级完成 (实际的)

2017年11月20日

研究完成 (实际的)

2017年11月20日

研究注册日期

首次提交

2016年4月26日

首先提交符合 QC 标准的

2016年6月16日

首次发布 (估计)

2016年6月21日

研究记录更新

最后更新发布 (实际的)

2022年4月29日

上次提交的符合 QC 标准的更新

2022年4月22日

最后验证

2022年4月1日