Non-Invasive Chromosomal Evaluation of Trisomy Study

This study is being conducted to provide clinically annotated samples to support continued improvements in the Ariosa Test content, methodology, specimen processing and quality control.

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Key information

Conditions

Aneuploidy Abnormalities, Multiple Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Aberrations Chromosome Disorders Chromosome Duplication Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Trisomy Trisomy 13 Trisomy 13 Syndrome Trisomy 18 Trisomy 18 Syndrome Trisomy 21

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

University California San Diego, San Diego, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Subject is at least 18 years old and can provide informed consent;
2. Subject has a viable singleton or twin pregnancy;
3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
4. Subject is planning to undergo CVS and/or amniocentesis for the purpose of genetic analysis of the fetus OR the subject has already undergone CVS and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.

Exclusion criteria

1. Subject has known aneuploidy;
2. Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
3. Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
4. Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant;

Treatment and study plan

Primary outcomes

Detection of aneuploidy

Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Cindy Cisneros

Industry

Registry information

Acronym: NICHE

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Jul 28, 2014
Registry last updated: Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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