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"Circulating Fetal DNA, Pregnancy And Immune Diseases"

NCT04155086 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2019-11-07

No results posted yet for this study

Summary

In the plasma of any pregnant patient circulates DNA (also called circulating free DNA). The vast majority of this circulating free DNA is of maternal origin and about 10% is of fetal origin (fetal circulating free DNA). This percentage of fetal circulating free DNA (corresponding to the fetal fraction) increases with gestation.

The pathophysiological hypothesis of this research is that there is a change in the fetal fraction (FF) of fetal circulating free DNA in patients with autoimmune disease (AID). The underlying mechanism would be a massive release of maternal cfDNA responsible for a dilution of fetal cfDNA. This dilution of fetal cfDNA would result in a decrease in the estimate of the foetal fraction of circulating free DNA. However, when the foetal fraction of circulating free DNA is insufficient (4% most often), screening for Trisomy 21 (T21) by fetal circulating free DNA becomes uninterpretable (NC for "non-contributory" result), and cannot be used to assess the risk of T21. In this case, the dose of fetal circulating free DNA can be performed again after 15 days, as the amount of fetal circulating free DNA increases with gestation. In a small number of cases the result will remain NC.

As tests using DNA are becoming more widespread, it is important to prospectively evaluate the results of these tests in the population of patients with AID, which represents about 3 to 5% of pregnant women.

Conditions

Interventions

BIOLOGICAL

the detection of the risk of fetal trisomy 21 by blood tests : free fetal DNA circulant analysis

The detection of the risk of fetal trisomy 21 by blood tests by 2 tests : free fetal DNA circulant analysis and first trimester serum screening

Sponsors & Collaborators

  • CERBA laboratory

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2020-01-31
Completion
2022-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04155086 on ClinicalTrials.gov