Non-Invasive Chromosomal Evaluation of Trisomy Study (NICHE)

April 28, 2020 updated by: Cindy Cisneros
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection of aneuploidy
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cindy Cisneros

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2014

Primary Completion (ACTUAL)

August 1, 2019

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (ESTIMATE)

July 28, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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