An observational study in Down Syndrome and Edwards Syndrome, sponsored by Progenity, Inc.. Status unknown at 10 sites in United States. Open to female participants aged 18 Years to 54 Years. Per ClinicalTrials.gov, last updated 2018-08-28.
Sponsored by Progenity, Inc. · Observational
The purpose of this study is to detect whole chromosome abnormalities in maternal blood.
The purpose of this study is to detect whole chromosome abnormalities on all chromosomes 13, 16, 18, 21, X and Y, in the fetus through analysis of cell free and compound sample DNA (cf DNA and cs DNA, respectively) in maternal blood. In addition, major deletions and duplications in chromosomes 1, 4, 5, and 22 will be detected.
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's planned enrollment of 340 is above the median of 150 across 141 observational studies indexed under Down Syndrome.
Browse Down Syndrome studies →Progenity, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women who are scheduled to undergo an amniocentesis or CVS procedure and will receive the fetal FISH and/or karyotype results from the procedure.
Subject is a pregnant woman 18-54 years of age at 8-22 weeks' gestation inclusive;
Exclusion Criteria:
Subjects will not be entered into this study if they meet the following criteria:
Pregnant women who are scheduled to undergo an amniocentesis or chorionic villus sampling (CVS) procedure Intervention: Single Maternal blood draw of 20mL
Other: Maternal Blood Draw
Maternal Blood Draw
Validate the prenatal aneuploidy laboratory developed test (LDT) with maternal blood samples from pregnant women who are undergoing invasive prenatal diagnosis
A single 20 mL blood sample will be obtained from each subject during the first or second trimester, blind-coded, and transferred to the Sponsor Laboratory for processing to plasma. Subjects electing to undergo an invasive procedure for fetal Karyotyping (defined as standard cytogenetics and/or microarray, FISH, QF-PCR) will have the blood sample obtained prior to the procedure. The performance characteristics (sensitivity, specificity, negative and positive predictive value) of the laboratory developed test to detect whole chromosome abnormalities on all chromosomes 13, 16, 18, 21, X and Y will be determined using fetal karyotype on specimens obtained by chorionic villus sampling and/or genetic amniocentesis for those subjects who undergo these diagnostic procedures as part of their standard care as the gold standard.
Time frame: Participants will have a single visit and completion in study occurs once invasive procedure results have been recorded.
Plan to share: Undecided
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Progenity, Inc.