search
Back to results

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

Primary Purpose

Trisomy 21, 18 and 13 Screening

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Genetic NIPT
Regular serum screening
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Trisomy 21, 18 and 13 Screening focused on measuring cell free fetal DNA, general population, screening, trisomy 21, IVF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • AP-HP, Antoine Béclère Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Genetic NIPT and regular serum screening

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 8, 2015
Last Updated
August 11, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT02424474
Brief Title
T21,18 and 13 Screening by Cell Free Fetal DNA in Low Risk Patients
Acronym
DEPOSA
Official Title
Fetal Aneuploidies Screening (21,18 and 13) by Cell Free Fetal DNA Analysis. Pilot Study in Low Risk Population and Pregnant Women After in Vitro Fertilisation (IFV)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
February 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trisomy 21, 18 and 13 Screening
Keywords
cell free fetal DNA, general population, screening, trisomy 21, IVF

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
933 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genetic NIPT and regular serum screening
Arm Type
Experimental
Arm Description
All woman will be tested using the two tests, genetic NIPT (Non Invasive Prenatal Testing) and regular serum screening.
Intervention Type
Device
Intervention Name(s)
Genetic NIPT
Intervention Description
Both tests are realized in a population of pregnant women (with and without in vitro fertilisation (IVF)) concomitantly at the same time.
Intervention Type
Biological
Intervention Name(s)
Regular serum screening
Other Intervention Name(s)
Usual screening
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Diagnostic performance measured by positive predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening
Description
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Benachi, MD, PhDi
Organizational Affiliation
AP-HP, Antoine Béclère Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HP, Antoine Béclère Hospital
City
Clamart
ZIP/Postal Code
92141
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30509296
Citation
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.
Results Reference
derived
PubMed Identifier
29493578
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs