Development of a Non-invasive Prenatal Test

NCT ID: NCT01451684

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

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2019-12-31

Brief Summary

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This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.

Detailed Description

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Blood samples and information collected for the study will be used for test development and quality control purposes. No test results will be communicated back to study subjects or their health care providers.

Conditions

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Pregnancy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subject has singleton or twin pregnancy confirmed via evaluation by a healthcare provider
* Subject is able to provide informed consent
* Subject is ≥ 18 years of age
* Subject is at least 10 weeks gestation for general enrollment
* Subject has no known risk factors for chromosomal abnormalities of the fetus
* Subject has no suspected or confirmed fetal abnormalities

Exclusion Criteria

* Subject is pregnant with more than two fetuses
* Subject is unwilling to undergo a blood draw
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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Ariosa Diagnostics

San Jose, California, United States

Site Status

Countries

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United States

Other Identifiers

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TD003

Identifier Type: -

Identifier Source: org_study_id

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