Ignite Creation Date:
2024-07-17 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471335
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-17
Brief Title:
Fetal Alcohol Spectrum Disorder Clinical Description and Search for Epigenetic Biomarker EPI-TSAF
Sponsor:
Centre Hospitalier Universitaire de la Réunion
Organization:
Centre Hospitalier Universitaire de la Réunion
Study Overview
Official Title:
Fetal Alcohol Spectrum Disorder FASD Clinical Description and Search for Epigenetic Biomarkers for Diagnostic Purposes
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPI-TSAF
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None