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CompletedNCT02424474DEPOSAUpdated Aug 15, 2017

T21,18 and 13 Screening by Cell Free Fetal DNA in Low Risk Patients

An interventional study of Genetic NIPT and Regular serum screening in Trisomy 21, 18 and 13 Screening, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-15.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
933
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

The purpose of this study is to evaluate the performance of non invasive screening in a population of pregnant women with and without in vitro fertilisation (IVF) concomitantly to regular first trimester trisomy 21 (T21) screening using maternal age, nucal fold measurement and serum screening.

Read the detailed description

All pregnant women in 9 institutions in France will be offer both regular first trimester screening for trisomy 21 (T21) and cell free DNA non invasive (NI) screening test at the same time. Specificity and the positive and negative predictive values of the NI test will be analysed. The population will be divided in women who did and did not get pregnant after an In vitro fertilisation (IVF) procedure.

02

Conditions studied

  • Trisomy 21, 18 and 13 Screening

Keywords

  • cell free fetal DNA
  • general population
  • screening
  • trisomy 21
  • IVF
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age >18
  • Singleton pregnancy
  • Having a spontaneous pregnancy or obtained by AMP ,
  • Having chosen to carry out a screening of the T21 to the first or second trimester of pregnancy ,
  • Gestational age >=10 weeks of amenorrhea
  • Consenting to invasive prenatal diagnosis,
  • Having health insurance,
  • Having signed the informed consent

Exclusion criteria

Exclusion Criteria:

  • The Patients whose fetus has an abnormality on the first trimester ultrasound including nuchal translucency > 3.5mm ,
  • Participant to another biomedical research.
  • Pregnancy twins including the presence of a twin vanishing
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
933 participants (actual)

Study arms

  • Experimental
    Genetic NIPT and regular serum screening

    All woman will be tested using the two tests, genetic NIPT (Non Invasive Prenatal Testing) and regular serum screening.

    Device: Genetic NIPT · Biological: Regular serum screening

Interventions

  • DeviceGenetic NIPT

    Both tests are realized in a population of pregnant women (with and without in vitro fertilisation (IVF)) concomitantly at the same time.

  • BiologicalRegular serum screening

    Also known as: Usual screening

05

What researchers measure

Primary outcomes

  1. Diagnostic performance measured by specificity (%) of genetic Non Invasive Prenatal Testing (NIPT) in the two populations (with and without IVF) compared to regular serum screening

    Time frame: Between the 11th and the 13th week of amenorrhea

Secondary outcomes

  1. Diagnostic performance measured by positive predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening

    positive ad negative predictive values of NIPT in the two populations of woman with and without IVF.

    Time frame: Between the 11th and the 13th week of amenorrhea

  2. Diagnostic performance measured by negative predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening

    Time frame: Between the 11th and the 13th week of amenorrhea

06

Study locations

1 site
  • AP-HP, Antoine Béclère Hospital
    Clamart, 92141, France
07

References and documents

Publications

  • Dabi Y, Guterman S, Jani JC, Letourneau A, Demain A, Kleinfinger P, Lohmann L, Costa JM, Benachi A. Autoimmune disorders but not heparin are associated with cell-free fetal DNA test failure. J Transl Med. 2018 Dec 3;16(1):335. doi: 10.1186/s12967-018-1705-2. PubMed 30509296 ↗
  • Costa JM, Letourneau A, Favre R, Bidat L, Belaisch-Allart J, Jouannic JM, Quarello E, Senat MV, Broussin B, Tsatsaris V, Demain A, Kleinfinger P, Lohmann L, Agostini H, Bouyer J, Benachi A. Cell-free fetal DNA versus maternal serum screening for trisomy 21 in pregnant women with and without assisted reproduction technology: a prospective interventional study. Genet Med. 2018 Nov;20(11):1346-1353. doi: 10.1038/gim.2018.4. Epub 2018 Mar 1. PubMed 29493578 ↗
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Registry details

Key details

Study ID
NCT02424474
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Apr 23, 2015
Start date
Jun 2015
Primary completion
Sep 2016
Completion
Feb 14, 2017
Last update
Aug 15, 2017

Study contacts

Alexandra Benachi, MD, PhDi
principal investigator · AP-HP, Antoine Béclère Hospital

Oversight

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

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