CompletedNot Applicable

Fetal Alcohol Spectrum Disorder : Clinical Description and Search for Epigenetic Biomarker (EPI-TSAF)

France188 participantsStarted 2024-06-12

Plain-language 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 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.

Who can participate

Age range

1 Year – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 : * 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 Exclusion Criteria: 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical description of a series of Fetal Alcohol Spectrum Disorder patients from Reunion Island (part 1)

Timeframe: 6 months

Clinical description of a series of Fetal Alcohol Spectrum Disorder patients from Reunion Island (part2)

Timeframe: 6 months

Trial details

NCT IDNCT06471335

SponsorCentre Hospitalier Universitaire de la Réunion

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-22

View on ClinicalTrials.gov More Fetal Alcohol Spectrum Disorders trials