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Trials / Recruiting

RecruitingNCT05995171

Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

Status
Recruiting
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
13 Years – 14 Years
Healthy volunteers
Not accepted

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 13/14, 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 biobank's 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.

Conditions

Interventions

TypeNameDescription
OTHERQuestionnaireQuality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL

Timeline

Start date
2023-11-14
Primary completion
2026-11-14
Completion
2026-11-14
First posted
2023-08-16
Last updated
2026-02-20

Locations

33 sites across 3 countries: France, Martinique, Reunion

Source: ClinicalTrials.gov record NCT05995171. Inclusion in this directory is not an endorsement.