NCT01451671

Brief Summary

This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

9 years

First QC Date

October 10, 2011

Last Update Submit

April 28, 2020

Conditions

Fetal Complications

Keywords

fetalaneuploidynon-invasiveprenatalcell free DNA

Outcome Measures

Primary Outcomes (1)

  • Identification of aneuploidy

    At enrollment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women carrying a fetus with an abnormal chromosomal condition that has been confirmed by invasive testing.

You may qualify if:

  • Subject has singleton pregnancy
  • Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality
  • Subject is able to provide informed consent
  • Subject is ≥ 18 years of age

You may not qualify if:

  • Subject is pregnant with more than one fetus
  • Subject (mother) has a known aneuploidy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California San Diego

San Diego, California, 92037, United States

Location

Norton Healthcare

Louisville, Kentucky, 40202, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Aneuploidy

Condition Hierarchy (Ancestors)

Chromosome AberrationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tracy Roberts

    Ariosa Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
CRA

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 14, 2011

Study Start

November 1, 2010

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

April 30, 2020

Record last verified: 2020-04

Locations

US(3)