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CompletedNCT02201862NICHEUpdated Apr 30, 2020

Non-Invasive Chromosomal Evaluation of Trisomy Study

An observational study in Aneuploidy, Trisomy 21 and Trisomy 18, sponsored by Cindy Cisneros. Completed at 3 sites in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-30.

Sponsored by Cindy Cisneros · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Aneuploidy
  • Trisomy 21
  • Trisomy 18
  • Trisomy 13
  • Down Syndrome

Keywords

  • Aneuploidy
  • Down Syndrome
  • amniocentesis
  • chronic villus sampling
  • Trisomy
  • non-invasive prenatal testing
  • Chromosome disorders
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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;
    1. Subject has a viable singleton or twin pregnancy;
    1. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
    1. 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

Exclusion Criteria:

    1. Subject has known aneuploidy;
    1. Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
    1. Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
    1. Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant;
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,000 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Euploid Subjects

    Subject's with fetal euploidy confirmed by chromosome analysis

  • Aneuploid Subjects

    Subject's with fetal aneuploidy confirmed by chromosome analysis

05

What researchers measure

Primary outcomes

  1. Detection of aneuploidy

    Time frame: 24 months

06

Study locations

3 sites
  • University California San Diego
    San Diego, California, United States
  • Women's Healthcare Group of PA
    Oaks, Pennsylvania 19456, United States
  • Regional Obestrical Consultants
    Chattanooga, Tennessee 37403, United States
07

References and documents

Publications

  • Norton ME, Brar H, Weiss J, Karimi A, Laurent LC, Caughey AB, Rodriguez MH, Williams J 3rd, Mitchell ME, Adair CD, Lee H, Jacobsson B, Tomlinson MW, Oepkes D, Hollemon D, Sparks AB, Oliphant A, Song K. Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8. doi: 10.1016/j.ajog.2012.05.021. Epub 2012 Jun 1. PubMed 22742782 ↗
08

Registry details

Key details

Study ID
NCT02201862
Lead sponsor
Cindy Cisneros
Responsible party
Cindy Cisneros (CRA, Roche Sequencing Solutions) — Sponsor-investigator
First posted
Jul 28, 2014
Start date
Apr 2014
Primary completion
Aug 1, 2019
Completion
Aug 1, 2019
Last update
Apr 30, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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