ClinicalTrials.gg
CompletedNCT01256606Updated Jan 10, 2013

Prenatal Test for Fetal Aneuploidy Detection

An observational study in Aneuploidy and Trisomy 21, sponsored by Roche Sequencing Solutions. Completed at 6 sites in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-10.

Sponsored by Roche Sequencing Solutions (part of Hoffmann-La Roche) · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
4,000
Ages
18 Years to 60 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 31 studies in Aneuploidy with a site in United States — 6 open to participants now, 8 under way, none of them phase 3. Aneuploidy · United States.

Enrollment
4th of 17
4,000 · median 2,000
Started
2010
with 1 other
Observational
17 of 31
4 open now
Registered
6th of 31
by date

Among the 31 studies in Aneuploidy with a site in United States, this one is the 4th largest by enrollment of the 17 observational ones, is one of 2 that started in 2010, is one of 17 observational ones, and was the 6th registered.

By phase

31 studies; the count open now beside each. This study's row is marked.

Observationalthis study17 · 4 open
No phase13 · 2 open
Phase 41 · 0 open

By the year they started

First in 2008; this study’s year is marked. 2 started in 2010.

What they test

Size and results

Median enrollment 202 across the 14 interventional studies, 2,000 across the 17 observational. Of the 20 that completed or were terminated, 3 (15%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 31 studies in Aneuploidy with a site in United States, or all of them as a file.
02

Study summary

The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.

03

Conditions studied

  • Aneuploidy
  • Trisomy 21
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant women planning to undergo chorionic villus sampling or amniocentesis for fetal genetic evaluation

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 18yrs or older
  • Subject has a singleton pregnancy
  • Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy
  • Subject is able to provide consent

Exclusion criteria

Exclusion Criteria:

  • Subject is pregnant with more than one fetus
  • Subject (mother) has known aneuploidy
  • Subject has active requiring major surgery or systemic chemotherapy or has a history of cancer.
  • Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.
Terms in these criteria, in plain language(2)

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
4,000 participants (actual)

Groups and cohorts

  • Positive for fetal aneuploidy
  • Negative for fetal aneuploidy
06

What researchers measure

Primary outcomes

  1. Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection

    Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis.

    Time frame: 24 months

07

Study locations

6 sites
  • East Bay Perinatal Medical Associates
    Oakland, California 94609, United States
  • Prenatal Diagnosis of Northern California
    Sacramento, California 95815, United States
  • University of California - San Diego
    San Diego, California 92121, United States
  • University of California - San Francisco
    San Francisco, California 94122, United States
  • Atlanta Perinatal Consultants
    Atlanta, Georgia 30342, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

References and documents

Related links

09

Timeline

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

The record gives a start of Aug 2010, a primary completion of Nov 2011 and a completion of Nov 2011. 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
Nov 22, 2010
First posted
Dec 8, 2010
Start
Aug 2010
Primary completionActual
Nov 2011
CompletionActual
Nov 2011
Last update
Jan 10, 2013
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 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01256606
Responsible party
Sponsor
First posted
Dec 8, 2010
Start date
Aug 2010
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Jan 10, 2013

Study contacts

Ken Song, MD
study director · Ariosa Diagnostics

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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