Development of a Prenatal Test for Fetal Aneuploidy Detection

NCT ID: NCT01451671

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fetal Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Subject is pregnant with more than one fetus
* Subject (mother) has a known aneuploidy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cindy Cisneros

INDUSTRY

Sponsor Role lead

Responsible Party

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Cindy Cisneros

CRA

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tracy Roberts

Role: STUDY_DIRECTOR

Ariosa Diagnostics

Locations

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University of California San Diego

San Diego, California, United States

Site Status

Norton Healthcare

Louisville, Kentucky, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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TD002

Identifier Type: -

Identifier Source: org_study_id

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