ClinicalTrials.gg
CompletedNCT00770458Updated Jan 6, 2010

Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

An observational study in Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18) and Patau Syndrome (Trisomy 13), sponsored by Sequenom, Inc.. Completed at 7 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-06.

Sponsored by Sequenom, Inc. (part of Labcorp) · Observational

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 204 studies in Down Syndrome with a site in United States — 47 open to participants now, 55 under way, 4 of them phase 3. Down Syndrome · United States.

Planned enrollment
25th of 74
1,000 · median 433
Started
2008
with 6 others
Observational
74 of 204
14 open now
Registered
14th of 204
by date
Lead sponsor
8 of 204
Sequenom, Inc.

Among the 204 studies in Down Syndrome with a site in United States, this one is the 25th largest by planned enrollment of the 74 observational ones that give a count, is one of 7 that started in 2008, is one of 74 observational ones, and was the 14th registered.

Down Syndrome

438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.

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Open to participants now

47 of the 204 studies in Down Syndrome with a site in United States are open now. Recruiting first, the newest first:

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All 47 open studies →

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 →

Who these studies take

Of the 75 Down Syndrome studies recruiting now, 14 (19%) set no upper age limit and 58 (77%) stop at 75 or younger; 61 take children under 18; 19 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

Study summary

Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.

03

Conditions studied

  • Down Syndrome (Trisomy 21)
  • Edwards Syndrome (Trisomy 18)
  • Patau Syndrome (Trisomy 13)
  • Turner Syndrome

Keywords

  • Down Syndrome
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Fetal care and genetic counseling patients.

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.

Inclusion criteria

  • Subject is female
  • Subject is pregnant
  • Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure
  • Subject is willing to provide blood specimen

Exclusion criteria

Exclusion Criteria:

  • Subject is not pregnant
  • Subject is not willing to provide blood specimen
  • Subject is not haveing aneuploid screening
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Pregnant women

    Pregnant women that will undergo standard of care procedures to evaluate fetus for Down Syndrome

06

What researchers measure

Primary outcomes

  1. Compare investigational assay results for Down Syndrome to standard of care results.

    Time frame: 3 months

07

Study locations

7 sites
  • UCSD Fetal Care & Genetics Center
    La Jolla, California 92037, United States
  • San Diego Perinatal Center
    San Diego, California 92123, United States
  • Obstetrix Medical Group of San Jose
    San Jose, California 95008, United States
  • Obstetrix Medical Group of Colorado
    Denver, Colorado 80218, United States
  • Women & Infants
    Providence, Rhode Island 02903, United States
  • A.R.U.P.
    Salt Lake City, Utah 84108, United States
  • Obstetrix Medical Group of Washington
    Seattle, Washington 98104, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2008, a primary completion of Oct 2009 and a completion of Dec 2009. 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.

Registered
Oct 8, 2008
First posted
Oct 10, 2008
Start
Jun 2008
Primary completionActual
Oct 2009
CompletionActual
Dec 2009
Last update
Jan 6, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00770458
Lead sponsor
Sequenom, Inc.
First posted
Oct 10, 2008
Start date
Jun 2008
Primary completion
Oct 2009
Completion
Dec 2009
Last update
Jan 6, 2010

Study contacts

Allan Bombard, MD
study director · Sequenom, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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