Development of a Non-invasive Prenatal Test

Cindy Cisneros1 site in 1 country15,000 target enrollmentJune 2011

ConditionsPregnancy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pregnancy
Sponsor: Cindy Cisneros
Enrollment: 15000
Locations: 1
Primary Endpoint: Absence of chromosomal abnormality
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

December 2019

Last Updated

6 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Cindy Cisneros

Responsible Party

Sponsor Investigator

Principal Investigator

Cindy Cisneros

CRA

Roche Sequencing Solutions

Eligibility Criteria

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