Prenatal Test for Fetal Aneuploidy Detection

Cindy Cisneros3 sites in 1 country1,500 target enrollmentNovember 2010

ConditionsFetal Complications

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fetal Complications
Sponsor: Cindy Cisneros
Enrollment: 1500
Locations: 3
Primary Endpoint: Identification of aneuploidy
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

November 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 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