Fetal Alcohol Spectrum DisordersEPI-TSAFNCT06471335
Fetal Alcohol Spectrum Disorder : Clinical Description and Search for Epigenetic Biomarker (EPI-TSAF)
A study testing Extraction of microRNAs extracted from plasma (4 ml recovered as part of treatment) and Extraction of microRNAs extracted from bucal swabs (act added for research). in people with Fetal Alcohol Spectrum Disorders, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
The goal of this clinical trial is to carry out a clinical description of a Reunionese series of patients (aged 0 to 18 inclusive) with Fetal Alcohol Spectrum Disorders followed up in the Genetics Department of the University Hospital in Reunion Island The aim is also to identify a specific "epigenetic signature" for… Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Extraction of microRNAs extracted from plasma (4 ml recovered as part of treatment) and Extraction of microRNAs extracted from bucal swabs (act added for research).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2024to 23 Oct 2024
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Fetal Alcohol Spectrum Disorder group :
- born in Reunion
- aged between 0 and 18 years old
- Having been exposed to alcohol during the prenatal period
- Have a diagnosis of Fetal Alcohol Spectrum Disorder by a referring physician
- Control group :
Show all 13Show fewer
- born in Réunion
- aged between 0 and 18 years old
- Be matched on the age and sex of the Fetal Alcohol Spectrum Disorder children sampled (n=18)
- Not having been exposed to alcohol during the prenatal period
- Not having been diagnosed with FASD
- Not have congenital malformations
- Not have neurodevelopmental disorders
Who cannot join
- Fetal Alcohol Spectrum Disorder group :
- patients with Fetal Alcohol Spectrum Disorder who also present another genetic syndrome.
- Control group :
- people who are not matched on the age and sex of the Fetal Alcohol Spectrum Disorder patients sampled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal Alcohol Spectrum Disorder (FASD): Clinical Description and Search for Epigenetic Biomarkers for Diagnostic Purposes.
The goal of this clinical trial is to carry out a clinical description of a Reunionese series of patients (aged 0 to 18 inclusive) with Fetal Alcohol Spectrum Disorders followed up in the Genetics Department of the University Hospital in Reunion Island The aim is also to identify a specific "epigenetic signature" for Fetal Alcohol Spectrum Disorder, in order to provide early diagnostic markers, determine the origin of the microRNAs identified and study the phenotypic-epigenetic relationship (microRNAs).
This research is descriptive and monocentric.
Read more
- retrospective on the clinical description of 182 Fetal Alcohol Spectrum Disorderpatients
- prospective on the microRNAs part, with 18 patients in the Fetal Alcohol Spectrum Disorder group and 18 in the control group (participants without Fetal Alcohol Spectrum Disorder).
For the 18 patients in the Fetal Alcohol Spectrum Disorder group, the doctor will take a blood sample (for genetic testing) during a scheduled consultation. A remaining 4 ml of blood will be collected for research purposes (Fetal Alcohol Spectrum Disorder group only). A buccal smear will also be taken for research.
For the 18 participants in the control group (healthy participants of the same age and sex as the Fetal Alcohol Spectrum Disorder group), only a buccal smear will be taken for research purposes during a consultation.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Extraction of microRNAs extracted from plasma (4 ml recovered as part of treatment), Extraction of microRNAs extracted from bucal swabs (act added for research).
- Keywords
- Fetal Alcohol Spectrum Disorders, epigenetic, microRNA
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction of microRNAs extracted from plasma (4 ml recovered as part of treatment)Diagnostic test
Comparison of these micro RNAs with the micro RNAs extracted from oral swabs (in Fetal Alcohol Spectrum Disorder group)
Extraction of microRNAs extracted from bucal swabs (act added for research).Diagnostic test
Comparison of the microRNAs extracted from the oral swabs of the Fetal Alcohol Spectrum Disorder group with the microRNAs extracted from the oral swabs of the without Fetal Alcohol Spectrum Disorder group
| Study group | Role | What they receive |
|---|---|---|
| Patients Fetal Alcohol Spectrum Disorder | Experimental | Patients with Fetal Alcohol Spectrum Disorder, male an female, aged 0 to 18 inclusive. Receives: Diagnostic Test: Extraction of microRNAs extracted from plasma (4 ml recovered as part of treatment); Diagnostic Test: Extraction of microRNAs extracted from bucal swabs (act added for research). |
| Participants without Fetal Alcohol Spectrum Disorder | Active comparator | Participants without Fetal Alcohol Spectrum Disorder, male an female, aged 0 to 18 inclusive. Receives: Diagnostic Test: Extraction of microRNAs extracted from bucal swabs (act added for research). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical description of a series of Fetal Alcohol Spectrum Disorder patients from Reunion Island (part 1)
Description of :
- maternal alcohol consumption in the prenatal period and paternal alcohol consumption in the preconception period :
- duration (in month)
- type (Beer, wine, strong alcohol, Multiple)
- frequency (DAILY/ WEEK/ WEEKEND/ FESTIVAL-OCCASIONAL/ SINGLE EPISODE )
- stage of exposure (Trimester : 1/2/ ≤ 2 /3/≤ 3)
- other associated toxicants : tobacco, cannabis, medications (Yes/ no/ suspicion)
- the course of the pregnancy and childbirth :
- age of the mother (in years)
- term of delivery (FULL-TERM/ MEDIUM PREMATURITY/ HIGH PREMATURITY/ VERY HIGH PREMATURITY)
- trimester of discovery of the pregnancy (trimester : 1, 2, 3)
- socio-family data
- family situation (ADOPTION/ MOTHER/ PARENTS/ FATHER)
- type of placement (FOSTER FAMILY/ HOME/ ADOPTIVE FAMILY/ THIRD PARTY/ NURSERY)
- age of placement (in years)
Measured: 6 months
Clinical description of a series of Fetal Alcohol Spectrum Disorder patients from Reunion Island (part2)
Description of :
- data from the medical and genetic assessment
- congenital malformations (Yes/ No)
- hearing assessment (Normal/ abnormal),
- Chromosome analysis on a DNA chip (Normal/ abnormal),
- fragile X (Normal/ abnormal)
- data from the neuropsychological and psychomotor assessment
- psychomotor delay (Yes/ No)
- motor impairments (Yes/ No)
- intellectual disability (Yes/ No) (IQ Value)
- cognitive impairments (VERY WEAK/ LIMITED/ MEDIUM WEAK/ MEDIUM/ MEDIUM STRONG/ SUPERIOR/ VERY SUPERIOR)
- oral language, executive functions, behavioral abnormalities (alter/preserve),
- data from paraclinical examinations :
- kidney ultrasound, cardiac ultrasound, Magnetic Resonance Imaging (Nomal/ Abnormal)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start12 Jun 2024
- Primary completion22 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This research is descriptive and monocentric research. * retrospective on the clinical description of the 182 Fetal Alcohol Spectrum Disorder patients * prospective on the microRNAs part with 18 patients in Fetal Alcohol Spectrum Disorder group and 18 people in the control group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471335
- Sponsor's protocol ID
- 2024-A00029-38
- Acronym
- EPI-TSAF
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Alcohol Spectrum Disorder (FASD): Clinical Description and Search for Epigenetic Biomarkers for Diagnostic Purposes.
- ClinicalTrials.gov ID
- NCT06471335
- Acronym / sponsor ID
- EPI-TSAF / 2024-A00029-38
- Conditions
- Fetal Alcohol Spectrum Disorders
- Keywords
- Fetal Alcohol Spectrum Disorders, epigenetic, microRNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 24 Jun 2024 (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.
The goal of this clinical trial is to carry out a clinical description of a Reunionese series of patients (aged 0 to 18 inclusive) with Fetal Alcohol Spectrum Disorders followed up in the Genetics Department of the University Hospital in Reunion Island The aim is also to identify a specific "epigenetic signature" for Fetal Alcohol Spectrum Disorder, in order to provide early diagnostic markers, determine the origin of the microRNAs identified and study the phenotypic-epigenetic relationship (microRNAs).
This research is descriptive and monocentric.
- retrospective on the clinical description of 182 Fetal Alcohol Spectrum Disorderpatients
- prospective on the microRNAs part, with 18 patients in the Fetal Alcohol Spectrum Disorder group and 18 in the control group (participants without Fetal Alcohol Spectrum Disorder).
For the 18 patients in the Fetal Alcohol Spectrum Disorder group, the doctor will take a blood sample (for genetic testing) during a scheduled consultation. A remaining 4 ml of blood will be collected for research purposes (Fetal Alcohol Spectrum Disorder group only). A buccal smear will also be taken for research.
For the 18 participants in the control group (healthy participants of the same age and sex as the Fetal Alcohol Spectrum Disorder group), only a buccal smear will be taken for research purposes during a consultation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research is descriptive and monocentric research. * retrospective on the clinical description of the 182 Fetal Alcohol Spectrum Disorder patients * prospective on the microRNAs part with 18 patients in Fetal Alcohol Spectrum Disorder group and 18 people in the control group
| Arm | Type | Receives |
|---|---|---|
| Patients Fetal Alcohol Spectrum Disorder | Experimental | Diagnostic Test: Extraction of microRNAs extracted from plasma (4 ml recovered as part of treatment), Diagnostic Test: Extraction of microRNAs extracted from bucal swabs (act added for research).Patients with Fetal Alcohol Spectrum Disorder, male an female, aged 0 to 18 inclusive. |
| Participants without Fetal Alcohol Spectrum Disorder | Active comparator | Diagnostic Test: Extraction of microRNAs extracted from bucal swabs (act added for research).Participants without Fetal Alcohol Spectrum Disorder, male an female, aged 0 to 18 inclusive. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- born in Reunion
- aged between 0 and 18 years old
- Having been exposed to alcohol during the prenatal period
- Have a diagnosis of Fetal Alcohol Spectrum Disorder by a referring physician
- born in Réunion
Key exclusion criteria (4 listed)
- patients with Fetal Alcohol Spectrum Disorder who also present another genetic syndrome.
- people who are not matched on the age and sex of the Fetal Alcohol Spectrum Disorder patients sampled
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 |
|---|---|---|
| Extraction of microRNAs extracted from plasma (4 ml recovered as part of treatment)Comparison of these micro RNAs with the micro RNAs extracted from oral swabs (in Fetal Alcohol Spectrum Disorder group) | Diagnostic test | Patients Fetal Alcohol Spectrum Disorder |
| Extraction of microRNAs extracted from bucal swabs (act added for research).Comparison of the microRNAs extracted from the oral swabs of the Fetal Alcohol Spectrum Disorder group with the microRNAs extracted from the oral swabs of the without Fetal Alcohol Spectrum Disorder group | Diagnostic test | Participants without Fetal Alcohol Spectrum Disorder, Patients Fetal Alcohol Spectrum Disorder |
Primary outcome
Clinical description of a series of Fetal Alcohol Spectrum Disorder patients from Reunion Island (part 1)
Time frame: 6 months
Description of : * maternal alcohol consumption in the prenatal period and paternal alcohol consumption in the preconception period : * duration (in month) * type (Beer, wine, strong alcohol, Multiple) * frequency (DAILY/ WEEK/ WEEKEND/ FESTIVAL-OCCASIONAL/ SINGLE EPISODE ) * stage of exposure (Trimester : 1/2/ ≤ 2 /3/≤ 3) * other associated toxicants : tobacco, cannabis, medications (Yes/ no/ suspicion) * the course of the pregnancy and childbirth : * age of the mother (in years) * term of delivery (FULL-TERM/ MEDIUM PREMATURITY/ HIGH PREMATURITY/ VERY HIGH PREMATURITY) * trimester of discovery of the pregnancy (trimester : 1, 2, 3) * socio-family data * family situation (ADOPTION/ MOTHER/ PARENTS/ FATHER) * type of placement (FOSTER FAMILY/ HOME/ ADOPTIVE FAMILY/ THIRD PARTY/ NURSERY) * age of placement (in years)
Clinical description of a series of Fetal Alcohol Spectrum Disorder patients from Reunion Island (part2)
Time frame: 6 months
Description of : * data from the medical and genetic assessment * congenital malformations (Yes/ No) * hearing assessment (Normal/ abnormal), * Chromosome analysis on a DNA chip (Normal/ abnormal), * fragile X (Normal/ abnormal) * data from the neuropsychological and psychomotor assessment * psychomotor delay (Yes/ No) * motor impairments (Yes/ No) * intellectual disability (Yes/ No) (IQ Value) * cognitive impairments (VERY WEAK/ LIMITED/ MEDIUM WEAK/ MEDIUM/ MEDIUM STRONG/ SUPERIOR/ VERY SUPERIOR) * oral language, executive functions, behavioral abnormalities (alter/preserve), * data from paraclinical examinations : * kidney ultrasound, cardiac ultrasound, Magnetic Resonance Imaging (Nomal/ Abnormal)
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 20 Jan 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Extraction of microRNAs extracted from plasma (4 ml recovered as part of treatment) and Extraction of microRNAs extracted from bucal swabs (act added for research). in people with Fetal Alcohol Spectrum Disorders, run by Centre Hospitalier Universitaire de la Réunion 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 13 inclusion and 4 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 20 Jan 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?
Clinical description of a series of Fetal Alcohol Spectrum Disorder patients from Reunion Island (part 1) (time frame: 6 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?
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 20 Jan 2026.