Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05995171
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-07-31
Brief Title:
Long Term Outcome of Easophageal Atresia Transmics Profiles in Adolescence
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Long Term Outcome of Easophageal Atresia Transmics Profiles in Adolescence
Status:
RECRUITING
Status Verified Date:
2024-09
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:
TransEAsome
Brief Summary:
Oesophageal atresia OAEA a malformation of the oesophagus present from birth is characterized by the interruption of the continuity of the oesophagus which then ends in a cul-de-sac Source Fimatho An operation is then required to restore continuity to the esophagus Although this operation enables the vast majority of children to survive the neonatal period health problems such as gastro-oesophageal reflux eating difficulties respiratory problems and growth problems persist throughout life
The aim of the project is to create a prospective cohort of adolescents aged 1314 nested in the national AO registry of adolescents born with esophageal atresia including a biobank of esophageal mucosa and plasma blood samples Once the clinical and omic data have been collected the data will be transferred to the France Cohortes information system for analysis in order to assess the long-term outcome of this rare disease and establish multi-omic profiles Once the clinical data have been collected and the omics data derived from analysis of the biobanks biological samples have been generated they will be analyzed by the project partners to assess the long-term outcome of OA and establish multiomic profiles The raw data will be available on the France Cohorte platform
The aim of the project is to create a prospective cohort of adolescents aged 1314 nested in the national AO registry of adolescents born with esophageal atresia including a biobank of esophageal mucosa and plasma blood samples Once the clinical and omic data have been collected the data will be transferred to the France Cohortes information system for analysis in order to assess the long-term outcome of this rare disease and establish multi-omic profiles Once the clinical data have been collected and the omics data derived from analysis of the biobanks biological samples have been generated they will be analyzed by the project partners to assess the long-term outcome of OA and establish multiomic profiles The raw data will be available on the France Cohorte platform
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