An observational study in Down Syndrome and Aneuploidy, sponsored by Sequenom, Inc.. Completed at 10 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2021-09-20.
Sponsored by Sequenom, Inc. (part of Labcorp) · Observational
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.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
This study's enrollment of 150 is close to the median of 158 across 145 observational studies indexed under Down Syndrome.
Browse Down Syndrome studies →Sequenom, Inc. is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
First submitted before Sequenom, Inc. became part of Labcorp.
Counted across the registry records on this site, refreshed daily.
Pregnant women who have been definitively diagnosed by amniocentesis, CVS or QF/PCR as carrying a fetus with aneuploidy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women who have been definitively diagnosed as carrying a fetus with aneuploidy.
Other: Maternal blood draw of 30 to 50ml
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.
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
Plan to share: No — Samples and data are used in research and development of a noninvasive prenatal test. However, sample data used in publications will be shared as per requirements of the journal.
No publications or documents are linked to this record.
The record gives a start of Nov 2009, a primary completion of Aug 2021 and a completion of Aug 2021. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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