An observational study in Trisomy 13, Trisomy 18 and Trisomy 21, sponsored by Natera, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-13.
Sponsored by Natera, Inc. · Observational
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Among 20 studies in Trisomy 13 Syndrome with a site in United States — 3 open to participants now, 3 under way, none of them phase 3. Trisomy 13 Syndrome · United States.
Among the 20 studies in Trisomy 13 Syndrome with a site in United States, this one is the 17th largest by enrollment of the 18 observational ones that give a count, is one of 4 that started in 2014, is one of 18 observational ones, and was the 11th registered.
26 studies on the registry are indexed under Trisomy 13 Syndrome; 3 are open to participants now.
Browse Trisomy 13 Syndrome studies →3 of the 20 studies in Trisomy 13 Syndrome with a site in United States are open now. Recruiting first, the newest first:
BillionToOne Inc. · Sites in United States
Women only
University of North Carolina, Chapel Hill · Sites in United States
Ages 18+ · Healthy volunteers
Children's National Research Institute · Sites in United States
Ages 12 mo–99 yrs · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 2 Trisomy 13 Syndrome studies recruiting now, 2 set no upper age limit and none stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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20 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 4 started in 2014.
This study's enrollment of 99 is below the median of 1,000 across 22 observational studies indexed under Trisomy 13 Syndrome.
Median enrollment 428 across the 2 interventional studies, 1,000 across the 18 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
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16 of 20 have an industry lead sponsor. The 10 most frequent:
Natera, Inc. is the lead sponsor of 36 studies on the registry; 11 are open to participants now.
Natera, Inc. has 8 studies filed under Trisomy 13 Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Trisomy 13 Syndrome with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than other currently available screening tests.
This will result in fewer unnecessary amniocenteses and Chorionic Villus Sample (CVS) procedures, which are associated with a risk of miscarriage.
Pregnant Women
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.
Pregnancy at high risk for genetic aneuploidy as defined below:
Ultrasound abnormalities indicative of aneuploidy
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.
women pregnant with twins or triplets at high risk for aneuploidy
Screening capability of proprietary algorithm in the form of a risk results classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.'
The primary outcome will be to confirm the diagnostic capability of NATUS risk results (a risk score eg 1:100) classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.' The outcome will be determined as a risk score given for samples collected. This outcome will be compared to the diagnostic testing results of ploidy status. The chromosomal status will be determined from the CVS or amniocentesis results, if available. A cheek swab or saliva sample will be collected from live-born children if there are no CVS or amniocentesis results. This will be used to determine the true ploidy status of the fetuses.
Time frame: 4 years
The record gives a start of Aug 2014, a primary completion of Dec 2018 and a completion of Mar 2019. 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 Jun 2019. You cannot join it, but the record below documents what was studied.
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