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CompletedNCT01451671Updated Apr 30, 2020

Development of a Prenatal Test for Fetal Aneuploidy Detection

An observational study in Fetal Complications, sponsored by Cindy Cisneros. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-30.

Sponsored by Cindy Cisneros · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
Female
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Study summary

This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.

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Conditions studied

  • Fetal Complications

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Keywords

  • fetal
  • aneuploidy
  • non-invasive
  • prenatal
  • cell free DNA
03

In context

Aneuploidy

73 studies on the registry are indexed under Aneuploidy; 10 are open to participants now.

This study's enrollment of 1,500 is above the median of 325 across 38 observational studies indexed under Aneuploidy.

Browse Aneuploidy studies →

Lead sponsor

Cindy Cisneros is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant women carrying a fetus with an abnormal chromosomal condition that has been confirmed by invasive testing.

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 has singleton pregnancy
  • Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality
  • Subject is able to provide
  • Subject is ≥ 18 years of age

Exclusion criteria

Exclusion Criteria:

  • Subject is pregnant with more than one fetus
  • Subject (mother) has a known aneuploidy
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,500 participants (actual)
06

What researchers measure

Primary outcomes

  1. Identification of aneuploidy

    Time frame: At enrollment

07

Study locations

3 sites
  • University of California San Diego
    San Diego, California 92037, United States
  • Norton Healthcare
    Louisville, Kentucky 40202, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01451671
Lead sponsor
Cindy Cisneros
Responsible party
Cindy Cisneros (CRA, Roche Sequencing Solutions) — Sponsor-investigator
First posted
Oct 14, 2011
Start date
Nov 2010
Primary completion
Nov 2019
Completion
Nov 2019
Last update
Apr 30, 2020

Study contacts

Tracy Roberts
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 Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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