PrenatalAnddiPrenatomeNCT03964441
ANDDI-PRENATOME - Feasibility Study for a " Fast " Pangenomic High Throughput Sequencing Analysis in Prenatal Diagnosis
An observational study of Prenatal and Genome-wide High Throughput Sequencing, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Prenatal diagnosis of genetic diseases is a real medical challenge. The discovery of antenatal abnormalities on ultrasound is frequent (5 to 10% of pregnancies), and when an abnormalities is seen on ultrasound, it raises the possibility of an underlying developmental anomaly. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prenatal, Genome-wide High Throughput Sequencing
- What is being tested?
- Invasive fetal sampling, blood sampling of mother and father, blood sampling from the mother to recover the circulating cell free fetal DNA and Parent interviews (optional organizational study)
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2019to 25 Jan 2024
- Phase
- Observational
- 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
Study population: Pregnant women with antenatal discovery of at least two obstetrical ultrasound abnormalities
Who may be able to join
- Pregnant women with antenatal discovery of at least two obstetric ultrasound abnormalities (2 major malformations, or 1 major malformation and 1 minor malformation, or 1 isolated malformation with a high probability of a genetic condition) : who undergo invasive antenatal sampling for CGH-array diagnosis ; who has already had an invasive antenatal sampling for the diagnosis of CGH-array and for which the fetal CGH-array has been found to be normal (sufficient fetal DNA or amniotic fluid should be available to allow exome sequencing to be performed without further amniotic fluid puncture).
- Pregnant woman and father aged 18 years or more
- Written consent provided by the pregnant woman and the father of the fetus
- Possibility of sufficient fetal specimen (amniotic fluid or fetal blood) to collect an additional sample for the pilot project
- Possibility of sampling the pregnant woman and the father of the foetus (peripheral blood)
- Pregnant woman and father of the fetus able to understand the study
Show all 10Show fewer
- Pilot Organizational Study:
- In addition to the inclusion \& exclusion criteria of the main study:
- Pregnant woman and biological father of fetus who provided oral consent to be interviewed
- Professionals (obstetrician, midwife, geneticist, biologist) agreeing to be interviewed
Who cannot join
- Diagnostic hypothesis considered highly probable that can be confirmed by an available molecular or cytogenetic test with a lower cost than ES (e. g. 22q11 microdeletion) or high suspicion of fetal infection (e. g. toxoplamosis seroconversion)
- Refusal of pregnant woman or father of fetus to participate in the study
- Pregnancy earlier than 15 weeks of amenorrhea or later than 34 weeks of amenorrhea
- Pregnant woman and father of the foetus not covered by the national health insurance system
- Pregnant woman and/or father of the fetus under partial judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Prenatal diagnosis of genetic diseases is a real medical challenge. The discovery of antenatal abnormalities on ultrasound is frequent (5 to 10% of pregnancies), and when an abnormalities is seen on ultrasound, it raises the possibility of an underlying developmental anomaly. Currently, in France, when abnormalities are discovered with an ultrasound scan, the etiological diagnosis is based on additional imaging tests (cerebral MRI, 3D bone tomography, fetal CT, fetal CT) or diagnostic tests such as invasive chorionic villus sampling, amniocentesis or fetal blood for infectious, metabolic, immunological and genetic investigations (standard karyotype, FISH (fluorescence in situ hybridization) for the rapid detection of aneuploidy, Chromosome Analysis on DNA Chip (ACPA or CGH-array) and possible sequencing of targeted genes when they are available within a time frame compatible with pregnancy). NIPT (Non-invasive prenatal testing) on cell free fetal DNA circulating in maternal blood has more limited indications, allowing, from an early stage of pregnancy, the determination of fetal sex and fetal rhesus factor and the search for aneuploidy.
However, establishing an etiological diagnosis during pregnancy has many benefits for the parents: clarifying the cause, obtaining a more precise prognosis to determine future management and outcome of the pregnancy, and establishing the risks of recurrence.
Read more
Over the past decade, medical genetics has undergone a real technological revolution, leading to the development of high throughput genome-wide, exome (ES) and genome (GS) sequencing. However, few countries have currently embarked on ES/GS in prenatal care, due to the constraints of time and the difficulty of interpreting genomic data when the clinical data is limited to antenatal imaging data.
In 2016, France launched the France Medicine Genomics 2025 Plan (PFMG2025) to deploy GS, particularly in the diagnosis of rare diseases. It is thus becoming essential to define the modalities of prescription of this testing, in particular during prenatal diagnosis. In parallel, from the first publications, the applications of genomic analysis on circulating fetal DNA seem to be able to extend to genome sequencing for research of SNVs responsible for developmental diseases.
The AnDDI-rares health network therefore proposes this ANDDI-PRENATOME pilot project to study the feasibility of a "rapid" analysis of ES in prenatal diagnosis from 61 fetuses with ultrasound abnormalities, as a first step before considering future cost-effectiveness (PRME) or care system performance (PREPS) studies in conjunction with the PFMG2025.
- Conditions
- Prenatal, Genome-wide High Throughput Sequencing
- Being tested
- Invasive fetal sampling, blood sampling of mother and father, blood sampling from the mother to recover the circulating cell free fetal DNA, Parent interviews (optional organizational study), parent questionnaire (optional organizational study), professional interviews (optional organizational study)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive fetal sampling, blood sampling of mother and fatherBiological
to perform an exome sequencing analysis in trio
blood sampling from the mother to recover the circulating cell free fetal DNABiological
to perform a sequencing analysis of the genome of circulating free fetal DNA
Parent interviews (optional organizational study)Other
Interview with a sociologist or psychologist to explore perceptions of ES and the impact of the results, expectations regarding certain types of results not currently available, the emotional situation, and position regarding the continuation of the pregnancy At 4 different times: at inclusion, at the time of the CGA-array results, at the time of the ES results and at a distance from the ES results
parent questionnaire (optional organizational study)Other
To evaluate the experience, perceptions, the impact of the analyses on the decision, satisfaction and concerns regarding the ES and its results, opinions on certain types of results not currently available, as well as anxiety and possible psychological distress At 4 different points in time: at inclusion, at the delivery of the CGA-array results, at the delivery of the ES results and at a distance from the delivery of the ES results
professional interviews (optional organizational study)Other
interview to understand how the decision is formed
Focus group for professionals (optional organizational study)Other
interview to specify whether variants of unknown significance) VUS will potentially be returned to the clinicians, or even to the patient via the clinician.
| Study group | Role | What they receive |
|---|---|---|
| control | fetus with at least 2 ultrasound abnormalities and both parents Receives: Biological: Invasive fetal sampling, blood sampling of mother and father; Other: Parent interviews (optional organizational study); Other: parent questionnaire (optional organizational study) | |
| comparison | fetus with at least 2 ultrasound abnormalities with ES diagnosis on invasive fetal sampling Receives: Biological: Invasive fetal sampling, blood sampling of mother and father; Biological: blood sampling from the mother to recover the circulating cell free fetal DNA; Other: Parent interviews (optional organizational study); Other: parent questionnaire (optional organizational study) | |
| professional | obstetrician, midwife, geneticist, biologist Receives: Other: professional interviews (optional organizational study); Other: Focus group for professionals (optional organizational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to return ES results to patients and their families in a context prenatal diagnosis
Measured: Through study completion, an average of 12 months
number of discrepancies between ES and WGS
Measured: Through study completion, an average of 12 months
Secondary outcomes (2)
Questionnaire to understand the expectations of couples and their a priori perception of ES
To define feelings and to know better how couples perceive ES and its implications and in particular the risk of discovery of VUS (variants of unknown significance) and ID (incidental data).
Measured: Through study completion, an average of 12 months
Questionnaire to evaluate the organization of health professionals involved in the decision-making process
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start20 Jun 2019
- Primary completion20 Dec 2021
- Study completion25 Jan 2024
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 PrenatalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964441
- Sponsor's protocol ID
- THAUVIN AnDDI rares 2018
- Acronym
- AnddiPrenatome
- Status last verified
- Jan 2026
- First submitted
- 22 May 2019
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tran Mau-Them F, Delanne J, Denomme-Pichon AS, Safraou H, Bruel AL, Vitobello A, Garde A, Nambot S, Bourgon N, Racine C, Sorlin A, Moutton S, Marle N, Rousseau T, Sagot P, Simon E, Vincent-Delorme C, Boute O, Colson C, Petit F, Legendre M, Naudion S, Rooryck C, Prouteau C, Colin E, Guichet A, Ziegler A, Bonneau D, Morel G, Fradin M, Lavillaureix A, Quelin C, Pasquier L, Odent S, Vera G, Goldenberg A, Guerrot AM, Brehin AC, Putoux A, Attia J, Abel C, Blanchet P, Wells CF, Deiller C, Nizon M, Mercier S, Vincent M, Isidor B, Amiel J, Dard R, Godin M, Gruchy N, Jeanne M, Schaeffer E, Maillard PY, Payet F, Jacquemont ML, Francannet C, Sigaudy S, Bergot M, Tisserant E, Ascencio ML, Binquet C, Duffourd Y, Philippe C, Faivre L, Thauvin-Robinet C. Prenatal diagnosis by trio exome sequencing in fetuses with ultrasound anomalies: A powerful diagnostic tool. Front Genet. 2023 Mar 23;14:1099995. doi: 10.3389/fgene.2023.1099995. eCollection 2023.
PubMed 37035737Thauvin-Robinet C, Garde A, Delanne J, Racine C, Rousseau T, Simon E, Francois M, Moutton S, Sylvie O, Quelin C, Morel G, Goldenberg A, Guerrot AM, Vera G, Gruchy N, Colson C, Boute O, Abel C, Putoux A, Amiel J, Guichet A, Isidor B, Deiller C, Wells C, Rooryck C, Legendre M, Francannet C, Dard R, Sigaudy S, Bruel AL, Safraou H, Denomme-Pichon AS, Nambot S, Asensio MH, Binquet C, Duffourd Y, Vitobello A, Philippe C, Faivre L, Tran-Mau-Them F, Bourgon N. Prenatal exome sequencing, a powerful tool for improving the description of prenatal features associated with genetic disorders. Prenat Diagn. 2024 Sep;44(10):1179-1197. doi: 10.1002/pd.6623. Epub 2024 Aug 13.
PubMed 39138116
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANDDI-PRENATOME - Feasibility Study for a " Fast " Pangenomic High Throughput Sequencing Analysis in Prenatal Diagnosis
- ClinicalTrials.gov ID
- NCT03964441
- Acronym / sponsor ID
- AnddiPrenatome / THAUVIN AnDDI rares 2018
- Conditions
- Prenatal, Genome-wide High Throughput Sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 28 May 2019 (actual)
- 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.
Prenatal diagnosis of genetic diseases is a real medical challenge. The discovery of antenatal abnormalities on ultrasound is frequent (5 to 10% of pregnancies), and when an abnormalities is seen on ultrasound, it raises the possibility of an underlying developmental anomaly. Currently, in France, when abnormalities are discovered with an ultrasound scan, the etiological diagnosis is based on additional imaging tests (cerebral MRI, 3D bone tomography, fetal CT, fetal CT) or diagnostic tests such as invasive chorionic villus sampling, amniocentesis or fetal blood for infectious, metabolic, immunological and genetic investigations (standard karyotype, FISH (fluorescence in situ hybridization) for the rapid detection of aneuploidy, Chromosome Analysis on DNA Chip (ACPA or CGH-array) and possible sequencing of targeted genes when they are available within a time frame compatible with pregnancy). NIPT (Non-invasive prenatal testing) on cell free fetal DNA circulating in maternal blood has more limited indications, allowing, from an early stage of pregnancy, the determination of fetal sex and fetal rhesus factor and the search for aneuploidy.
However, establishing an etiological diagnosis during pregnancy has many benefits for the parents: clarifying the cause, obtaining a more precise prognosis to determine future management and outcome of the pregnancy, and establishing the risks of recurrence.
Over the past decade, medical genetics has undergone a real technological revolution, leading to the development of high throughput genome-wide, exome (ES) and genome (GS) sequencing. However, few countries have currently embarked on ES/GS in prenatal care, due to the constraints of time and the difficulty of interpreting genomic data when the clinical data is limited to antenatal imaging data.
In 2016, France launched the France Medicine Genomics 2025 Plan (PFMG2025) to deploy GS, particularly in the diagnosis of rare diseases. It is thus becoming essential to define the modalities of prescription of this testing, in particular during prenatal diagnosis. In parallel, from the first publications, the applications of genomic analysis on circulating fetal DNA seem to be able to extend to genome sequencing for research of SNVs responsible for developmental diseases.
The AnDDI-rares health network therefore proposes this ANDDI-PRENATOME pilot project to study the feasibility of a "rapid" analysis of ES in prenatal diagnosis from 61 fetuses with ultrasound abnormalities, as a first step before considering future cost-effectiveness (PRME) or care system performance (PREPS) studies in conjunction with the PFMG2025.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | Biological: Invasive fetal sampling, blood sampling of mother and father, Other: Parent interviews (optional organizational study), Other: parent questionnaire (optional organizational study)fetus with at least 2 ultrasound abnormalities and both parents |
| comparison | – | Biological: Invasive fetal sampling, blood sampling of mother and father, Biological: blood sampling from the mother to recover the circulating cell free fetal DNA, Other: Parent interviews (optional organizational study), Other: parent questionnaire (optional organizational study)fetus with at least 2 ultrasound abnormalities with ES diagnosis on invasive fetal sampling |
| professional | – | Other: professional interviews (optional organizational study), Other: Focus group for professionals (optional organizational study)obstetrician, midwife, geneticist, biologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with antenatal discovery of at least two obstetrical ultrasound abnormalities
Key inclusion criteria (10 listed)
- Pregnant women with antenatal discovery of at least two obstetric ultrasound abnormalities (2 major malformations, or 1 major malformation and 1 minor malformation, or 1 isolated malformation with a high probability of a genetic condition) : who undergo invasive antenatal sampling for CGH-array diagnosis ; who has already had an invasive antenatal sampling for the diagnosis of CGH-array and for which the fetal CGH-array has been found to be normal (sufficient fetal DNA or amniotic fluid should be available to allow exome sequencing to be performed without further amniotic fluid puncture).
- Pregnant woman and father aged 18 years or more
- Written consent provided by the pregnant woman and the father of the fetus
- Possibility of sufficient fetal specimen (amniotic fluid or fetal blood) to collect an additional sample for the pilot project
- Possibility of sampling the pregnant woman and the father of the foetus (peripheral blood)
Key exclusion criteria (5 listed)
- Diagnostic hypothesis considered highly probable that can be confirmed by an available molecular or cytogenetic test with a lower cost than ES (e. g. 22q11 microdeletion) or high suspicion of fetal infection (e. g. toxoplamosis seroconversion)
- Refusal of pregnant woman or father of fetus to participate in the study
- Pregnancy earlier than 15 weeks of amenorrhea or later than 34 weeks of amenorrhea
- Pregnant woman and father of the foetus not covered by the national health insurance system
- Pregnant woman and/or father of the fetus under partial judicial protection
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 |
|---|---|---|
| Invasive fetal sampling, blood sampling of mother and fatherto perform an exome sequencing analysis in trio | Biological | comparison, control |
| blood sampling from the mother to recover the circulating cell free fetal DNAto perform a sequencing analysis of the genome of circulating free fetal DNA | Biological | comparison |
| Parent interviews (optional organizational study)Interview with a sociologist or psychologist to explore perceptions of ES and the impact of the results, expectations regarding certain types of results not currently available, the emotional situation, and position regarding the continuation of the pregnancy At 4 different times: at inclusion, at the time of the CGA-array results, at the time of the ES results and at a distance from the ES results | Other | comparison, control |
| parent questionnaire (optional organizational study)To evaluate the experience, perceptions, the impact of the analyses on the decision, satisfaction and concerns regarding the ES and its results, opinions on certain types of results not currently available, as well as anxiety and possible psychological distress At 4 different points in time: at inclusion, at the delivery of the CGA-array results, at the delivery of the ES results and at a distance from the delivery of the ES results | Other | comparison, control |
| professional interviews (optional organizational study)interview to understand how the decision is formed | Other | professional |
| Focus group for professionals (optional organizational study)interview to specify whether variants of unknown significance) VUS will potentially be returned to the clinicians, or even to the patient via the clinician. | Other | professional |
Primary outcome
Time required to return ES results to patients and their families in a context prenatal diagnosis
Time frame: Through study completion, an average of 12 months
number of discrepancies between ES and WGS
Time frame: Through study completion, an average of 12 months
2 secondary outcomes
Questionnaire to understand the expectations of couples and their a priori perception of ES
Time frame: Through study completion, an average of 12 months
Questionnaire to evaluate the organization of health professionals involved in the decision-making process
Time frame: Through study completion, an average of 12 months
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 3 Feb 2026.
- Results publication: PubMed 37035737Tran Mau-Them F, Delanne J, Denomme-Pichon AS, Safraou H, Bruel AL, Vitobello A, Garde A, Nambot S, Bourgon N, Racine C, Sorlin A, Moutton S, Marle N, Rousseau T, Sagot P, Simon E, Vincent-Delorme C, Boute O, Colson C, Petit F, Legendre M, Naudion S, Rooryck C, Prouteau C, Colin E, Guichet A, Ziegler A, Bonneau D, Morel G, Fradin M, Lavillaureix A, Quelin C, Pasquier L, Odent S, Vera G, Goldenberg A, Guerrot AM, Brehin AC, Putoux A, Attia J, Abel C, Blanchet P, Wells CF, Deiller C, Nizon M, Mercier S, Vincent M, Isidor B, Amiel J, Dard R, Godin M, Gruchy N, Jeanne M, Schaeffer E, Maillard PY, Payet F, Jacquemont ML, Francannet C, Sigaudy S, Bergot M, Tisserant E, Ascencio ML, Binquet C, Duffourd Y, Philippe C, Faivre L, Thauvin-Robinet C. Prenatal diagnosis by trio exome sequencing in fetuses with ultrasound anomalies: A powerful diagnostic tool. Front Genet. 2023 Mar 23;14:1099995. doi: 10.3389/fgene.2023.1099995. eCollection 2023.
- Derived from this study: PubMed 39138116Thauvin-Robinet C, Garde A, Delanne J, Racine C, Rousseau T, Simon E, Francois M, Moutton S, Sylvie O, Quelin C, Morel G, Goldenberg A, Guerrot AM, Vera G, Gruchy N, Colson C, Boute O, Abel C, Putoux A, Amiel J, Guichet A, Isidor B, Deiller C, Wells C, Rooryck C, Legendre M, Francannet C, Dard R, Sigaudy S, Bruel AL, Safraou H, Denomme-Pichon AS, Nambot S, Asensio MH, Binquet C, Duffourd Y, Vitobello A, Philippe C, Faivre L, Tran-Mau-Them F, Bourgon N. Prenatal exome sequencing, a powerful tool for improving the description of prenatal features associated with genetic disorders. Prenat Diagn. 2024 Sep;44(10):1179-1197. doi: 10.1002/pd.6623. Epub 2024 Aug 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prenatal and Genome-wide High Throughput Sequencing, run by Centre Hospitalier Universitaire Dijon 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 10 inclusion and 5 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 3 Feb 2026. 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?
Time required to return ES results to patients and their families in a context prenatal diagnosis (time frame: Through study completion, an average of 12 months). The study lists 2 primary outcomes in all. 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 NCT03964441, 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 3 Feb 2026.