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Non-Invasive Chromosomal Evaluation of Trisomy Study (NICHE)

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ClinicalTrials.gov Identifier: NCT02201862
Recruitment Status : Unknown
Verified July 2016 by Roche Sequencing Solutions.
Recruitment status was:  Recruiting
First Posted : July 28, 2014
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
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

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Non-Invasive Chromosomal Evaluation of Trisomy Study
Study Start Date : April 2014
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017


Group/Cohort
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
Plasma


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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02201862


Contacts
Contact: Romielle Aquino 408-209-9098 raquino@ariosadx.com
Contact: Thomas Musci, MD 408-229-7500 tmusci@ariosadx.com

Locations
United States, California
University California San Diego Recruiting
San Diego, California, United States
Contact: Louise Laurent, MD    760-242-1677    llaurent@ucsd.edu   
United States, Pennsylvania
Women's Healthcare Group of PA Completed
Oaks, Pennsylvania, United States, 19456
United States, Tennessee
Regional Obestrical Consultants Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: David Adair, MD       adair@rocob.com   
Sponsors and Collaborators
Roche Sequencing Solutions

Publications:
Responsible Party: Roche Sequencing Solutions
ClinicalTrials.gov Identifier: NCT02201862     History of Changes
Other Study ID Numbers: AD201
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016

Keywords provided by Roche Sequencing Solutions:
Aneuploidy
Down Syndrome
amniocentesis
chronic villus sampling
Trisomy
non-invasive prenatal testing
Chromosome disorders

Additional relevant MeSH terms:
Down Syndrome
Trisomy
Aneuploidy
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Chromosome Aberrations
Pathologic Processes
Chromosome Duplication