Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies

Sequenom, Inc.150 enrolled

Overview

To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. The NIPD result will be compared to the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR, and/or any commercially available NIPD test.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Down Syndrome Aneuploidy

Interventions

Maternal blood draw of 30 to 50mlOTHER

Maternal blood draw of 30 to 50mls during pregnancy. Blood may be drawn up to 5 times during the pregnancy between weeks 8 and 36 gestation.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is female * Subject is 18 years or older * Subject is no less than 8 and no more than 36 weeks gestation * Subject provides a signed and dated informed consent * Subject agrees to provide one or more 30-50mL blood sample(s) in accordance with the protocol * Subject has a current pregnancy in which the fetus is known to have chromosomal aneuploidy (e.g. T13, T18, T21) Exclusion Criteria: * Non-singleton pregnancy in which only one fetus is known to have a chromosomal aneuploidy

Locations (10)

Perinatal Care Associates

Phoenix, Arizona, United States

St. Joseph's Hospital and medical Center

Phoenix, Arizona, United States

Sharp Grossmount

San Diego, California, United States

Outcomes

Primary Outcomes

NIPD result compared to standard test results

Result of NIPD test will be compared to the standard test results obtained by karyotype, FISH, QF-PCR, and/or commerical NIPD result.

Time frame: baseline

Data from ClinicalTrials.gov

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