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Trial record 3 of 10 for:    AD201

Non-Invasive Chromosomal Evaluation of Trisomy Study (NICHE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02201862
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : April 30, 2020
Information provided by (Responsible Party):
Cindy Cisneros, Roche Sequencing Solutions

Brief Summary:
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.

Condition or disease
Aneuploidy Trisomy 21 Trisomy 18 Trisomy 13 Down Syndrome

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Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Non-Invasive Chromosomal Evaluation of Trisomy Study
Actual Study Start Date : April 2014
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

Euploid Subjects
Subject's with fetal euploidy confirmed by chromosome analysis
Aneuploid Subjects
Subject's with fetal aneuploidy confirmed by chromosome analysis

Primary Outcome Measures :
  1. Detection of aneuploidy [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women planning to undergo chorionic villus sampling (CVS) and/or amniocentesis for the purpose of genetic evaluation of the fetus.

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02201862

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United States, California
University California San Diego
San Diego, California, United States
United States, Pennsylvania
Women's Healthcare Group of PA
Oaks, Pennsylvania, United States, 19456
United States, Tennessee
Regional Obestrical Consultants
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
Cindy Cisneros
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Responsible Party: Cindy Cisneros, CRA, Roche Sequencing Solutions Identifier: NCT02201862    
Other Study ID Numbers: AD201
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Keywords provided by Cindy Cisneros, Roche Sequencing Solutions:
Down Syndrome
chronic villus sampling
non-invasive prenatal testing
Chromosome disorders
Additional relevant MeSH terms:
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Down Syndrome
Trisomy 13 Syndrome
Trisomy 18 Syndrome
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Chromosome Aberrations
Chromosome Duplication
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases