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Simple blood test could replace risky prenatal procedures for down syndrome

NCT ID NCT01118507

Diagnosis Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new blood test that looks at fetal DNA in the mother's blood to detect Down syndrome (trisomy 21) as early as the first trimester. Researchers enrolled 976 pregnant women at high risk and compared the blood test results to standard invasive methods. The goal was to see if this noninvasive approach could accurately identify affected pregnancies, potentially offering a safer alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a safe, noninvasive way to detect Down syndrome early in pregnancy, reducing the need for risky invasive tests.
What could go wrong
The test is still being validated and may not be as accurate as traditional methods. It also requires further study before widespread use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

976 people

The number who actually took part.

Start date

Mar 2010

Finished

Oct 2013

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

PREGNANT WOMEN

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years, * patient coming from one of multidisciplinary prenatal diagnosis center * having à high risk of trisomy of chromosome 21 estimated by combine screening \> 1/250 * 11 weeks of gestation or high * accepting invasive prenatal diagnosis of chromosomal abnormalities * accepting genetic analysis of blood circulating DNA * Patient accepting to sign the enlightened assent Exclusion Criteria: * Patient of less than 18 years * combine risk \< 1/250 * refusing invasive prenatal diagnosis of chromosomal abnormalities * refusing genetic analysis of blood circulating DNA * Patient refusing to sign the enlightened assent

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Conditions

The condition(s) this trial relates to.

translocation Down syndrome trisomy 21

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Trisomy 21 - translocation

Contacts and locations

Locations

  • Chi Poissy St Germain

    Poissy, 78300, France

  • Necker Enfants Malades

    Paris, 75015, France

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