Trisomy 21, 18 and 13 ScreeningDEPOSANCT02424474
T21,18 and 13 Screening by Cell Free Fetal DNA in Low Risk Patients
A study testing Genetic NIPT and Regular serum screening in people with Trisomy 21, 18 and 13 Screening, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Trisomy 21, 18 and 13 Screening
- What is being tested?
- Genetic NIPT and Regular serum screening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 933 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to 14 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Trisomy 21, 18 and 13 Screening
- Being tested
- Genetic NIPT, Regular serum screening
- Keywords
- cell free fetal DNA, general population, screening, trisomy 21, IVF
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic NIPTDevice
Both tests are realized in a population of pregnant women (with and without in vitro fertilisation (IVF)) concomitantly at the same time.
Regular serum screeningBiological
Also called Usual screening
| Study group | Role | What they receive |
|---|---|---|
| Genetic NIPT and regular serum screening | Experimental | All woman will be tested using the two tests, genetic NIPT (Non Invasive Prenatal Testing) and regular serum screening. Receives: Device: Genetic NIPT; Biological: Regular serum screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between the 11th and the 13th week of amenorrhea
Secondary outcomes (2)
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.
Measured: Between the 11th and the 13th week of amenorrhea
Diagnostic performance measured by negative predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening
Measured: Between the 11th and the 13th week of amenorrhea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2016
- Study completion14 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trisomy 21, 18 and 13 ScreeningStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 933 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Benachi, MD, PhDi, Principal investigator, AP-HP, Antoine Béclère Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424474
- Sponsor's protocol ID
- P141001
- Acronym
- DEPOSA
- Status last verified
- Sep 2016
- First submitted
- 8 Apr 2015
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
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 30509296Costa 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02424474
- Acronym / sponsor ID
- DEPOSA / P141001
- Conditions
- Trisomy 21, 18 and 13 Screening
- Keywords
- cell free fetal DNA, general population, screening, trisomy 21, IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 933 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genetic NIPT and regular serum screening | Experimental | Device: Genetic NIPT, Biological: Regular serum screeningAll woman will be tested using the two tests, genetic NIPT (Non Invasive Prenatal Testing) and regular serum screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic NIPTBoth tests are realized in a population of pregnant women (with and without in vitro fertilisation (IVF)) concomitantly at the same time. | Device | Genetic NIPT and regular serum screening |
| Regular serum screeningAlso: Usual screening | Biological | Genetic NIPT and regular serum screening |
Primary outcome
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
2 secondary outcomes
Diagnostic performance measured by positive 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Derived from this study: PubMed 30509296Dabi 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.
- Derived from this study: PubMed 29493578Costa 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.
Related trials for Trisomy 21, 18 and 13 Screening
Active, not recruitingObservational study
Evaluation of Fetal Bladder Emptying During the 11-14 Weeks' Ultrasound Examination as a Negative Predictive Marker for Chromosomal Abnormalities
Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Benachi, MD, PhDi principal investigator
AP-HP, Antoine Béclère Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic NIPT and Regular serum screening in people with Trisomy 21, 18 and 13 Screening, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02424474, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.