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NCT01451684 Clinical Trial

Development of a Non-invasive Prenatal Test

Pregnancy Clinical Trial

Official title:
Development of a Non-invasive Prenatal Test

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01451684
Other study ID # TD003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2011
Est. completion date December 2019

Study information
Verified date April 2020
Source Roche Sequencing Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 15000
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Ariosa Diagnostics San Jose California

Sponsors (1)
Lead Sponsor Collaborator
Cindy Cisneros

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absence of chromosomal abnormality At time of enrollment
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