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Clinical Trials/NCT01451671
NCT01451671CompletedNot Applicable

Prenatal Test for Fetal Aneuploidy Detection

Cindy Cisneros3 sites in 1 country1,500 target enrollmentStarted: November 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,500
Locations
3
Primary Endpoint
Identification of aneuploidy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Identification of aneuploidy

Time Frame: At enrollment

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Cindy Cisneros
Sponsor Class
Industry
Responsible Party
Sponsor Investigator
Principal Investigator

Cindy Cisneros

CRA

Roche Sequencing Solutions

Study Sites (3)

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