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OpenTrials
Completed

NCT Number: NCT01597063

Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies

Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled. Study blood will be collected in the first or second trimester at a scheduled prenatal screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will be followed until delivery and the birth outcome recorded.

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Key information

Conditions

Aneuploidy Abnormalities, Multiple Chromosome Aberrations Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Noninvasive Prenatal Screening Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–34 year

Sex eligibility

Female

Study type

Observational

Primary location

University of South Alabama, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnancy is 10-22 weeks gestation
  • Between 18-34 years of age inclusive at estimated date of delivery
  • No prenatal screening indicators for high risk including serum biochemical and ultrasound screening
  • No personal or family history of Down syndrome
  • Willing to provide written informed consent
  • Willing to provide a whole blood sample
  • Willing to provide access to medical records supporting fetal outcome

Exclusion criteria

  • Fetal demise at the time of the blood draw
  • Previous specimen donation under this protocol

Treatment and study plan

SEQureDx Trisomy Test

Device

Plasma samples obtained from maternal blood will be tested using the SEQureDx Trisomy Test, an in vitro diagnostic test that measures circulating cell-free fetal DNA. The test detects the relative quantity of chromosome 21, which is associated with trisomy 21.

Primary outcomes

  1. Estimate the false positive rate of SEQureDx Trisomy 21 Test

    Time frame: pregnancy outcome

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Relative Clinical Specificity Performance of the SEQureDx Trisomy Test in Pregnant Women at Low Risk for Fetal Chromosomal Aneuploidy

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
May 11, 2012
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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