Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence (TransEAsome)

University Hospital, Lille

Status

Enrolling

Conditions

Esophageal Atresia

Treatments

Other: Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT05995171

2022_0483

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

13 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

For the oesophageal atresia group :
Born with oesophageal atresia (EA) in France or in French overseas departments and territories
Anastomosis performed
Included into the ReNaTo registry
Aged 13 or 14 during the recruitment period
Patient willing to comply with all study procedures and duration
Patient will social security

For the blood sub-study :

Upper GI endoscopy performed as part of care between 13 and 14 years of age with esophageal mucosal biopsy sampling
Patient having given written consent to participate in the study

For the control arm:

Upper GI endoscopy performed as part of care between 10 and 14 years of age with oesophageal mucosal biopsy sampling
Upper GI endoscopy performed as part of care for chronic or acute digestive signs to rule out organic etiology (peptic esophagitis, gastric esophagitis, eosinophilic esophagitis or ulcer)
Normal endoscopy and histology
No chronic progressive disease

Exclusion criteria

For the oesophagal atresia arm :
Concurrent participation in an interventional trial and in the 3 months prior to inclusion
Parents refusing to participate in the study

For the control arm :