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Recruiting Observational

Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

NCT05995171 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-11-14
Last updated
2026-04-22

Condition(s) studied

Esophageal Atresia

Investigational drug(s) / intervention(s)

Questionnaire

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

Study 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.

Eligibility

Sex
ALL
Min age
13 Years
Max age
14 Years
Healthy volunteers
No
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 : * Histologically non-normal esophageal biopsy * Parents refusing to participate in the study * Child with known organic pathology

Primary outcome measure(s)

  • prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia — 13-14 years
    GERD = \[pH/impedance-metry demonstrating pathological GERD and/or if lesions of peptic esophagitis are observed at an endoscopy in the year preceding the visit or if the child has a history of complicated GERD leading to anti-reflux surgery\]

Trial sites (33)

FacilityCityRegionStatus
CHU de Lille Hôpital Jeanne de Flandre Lille Nord Recruiting
CHU Amiens Amiens France Not Yet Recruiting
CHU Angers Angers France Recruiting
CHU Besançon Besançon France Not Yet Recruiting
CHU Bordeaux Bordeaux France Recruiting
HLC Hôpital Mère Enfant Bron France Recruiting
CHU Caen Caen France Recruiting
CHU Clermont-Ferrand Clermont-Ferrand France Not Yet Recruiting
CHI Créteil Créteil France Recruiting
CHU Dijon Dijon France Recruiting
CHU Grenoble La Tronche France Not Yet Recruiting
AP-HP Hôpital Kremlin Bicêtre Le Kremlin-Bicêtre France Not Yet Recruiting
CHU Le Mans Le Mans France Not Yet Recruiting
CHU Limoges Limoges France Not Yet Recruiting
AP-HM Hôpital La Timone Marseille France Recruiting
CHU Montpellier Montpellier France Recruiting
CHU Nancy Hôpital Brabois Nancy France Not Yet Recruiting
CHU Nantes Nantes France Recruiting
CHU Nice Nice France Not Yet Recruiting
CHU Orléans Orléans France Not Yet Recruiting
AP-HP Hôpital Armand Trousseau Paris France Not Yet Recruiting
AP-HP Hôpital Necker Paris France Recruiting
AP-HP Hôpital Robert Debré Paris France Recruiting
CHU Poitiers Poitiers France Recruiting
CHU de Reims Reims France Not Yet Recruiting
CHU de Rennes Rennes France Recruiting
CHU Rouen Rouen France Not Yet Recruiting
CHU Saint Etienne Saint-Etienne France Not Yet Recruiting
CHU Strasbourg Strasbourg France Not Yet Recruiting
CHU Toulouse Toulouse France Not Yet Recruiting
CHU Tours Tours France Not Yet Recruiting
CHU Fort de France Fort-de-France Martinique Recruiting
CHU de Saint Denis de la Réunion Saint-Denis Reunion Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05995171 on ClinicalTrials.gov ↗ ← All trials in France