Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

Recruiting

• Conditions: Esophageal Atresia
• Interventions: Other: Questionnaire

• Registration Number: NCT05995171
• Lead Sponsor: University Hospital, Lille

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-16
• Study Start: 2023-11-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Primary Completion: 2026-11-14
• Study Completion: 2026-11-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• For the oesophagal atresia group :
• Born with oesophageal atresia (AO) in France or in French overseas departments and territories
• Operated at birth for an AO
• Aged 13 or 14 during the recruitment period
• Patient willing to comply with all study procedures and duration

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:

• Aged 13 or 14 during the recruitment period
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Esophageal atresia arm	Questionnaire	Patient with esophageal atresia
control arm	Questionnaire	Patient without esophageal atresia

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life, nutritional status and respiratory complications	13-14 years	Quality of life= EA-QoL and PedsQL The quality of life of patients in adolescence will be assessed by means of the following quality of life scales at the age of 13-14 years: PedsQL (13) and EA-QoL (11) by both the patient and a parent. Scale scores will be calculated in accordance with the authors' instructions.; * Nutritional status will be assessed by weight and height, and by calculating the weight/height z-score and BMI z-score using the World Health Organisation growth curves as a reference (14).; * Frequency of respiratory complications, assessed during clinical examination (hacking cough during infections, chronic cough, asthma, exertional symptoms (cough, dyspnoea), atopy, wheezing and/or stridor/corniness).
Omics and multi omics profiles in plasma	13-14 years
Factors associated with GERD	Birth,1 year, 6 years and 13-14 years	It will be determined from patient characteristics at birth, 1 year, 6 years and 13-14 years (ante-natal data, vital signs, presence of associated malformations, type of atresia, surgical procedures performed, surgical/digestive/respiratory/neuro-orthopaedic complications, type of diet and schooling).
Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsy	13-14 years	metabolites, proteins and methylation
Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsy	13-14 years	metabolites, proteins and methylation

Trial Locations

Locations (33)

CHU Amiens; 🇫🇷 Amiens, France

CHU Angers; 🇫🇷 Angers, France

CHU Besançon; 🇫🇷 Besançon, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

HLC Hôpital Mère Enfant; 🇫🇷 Bron, France

CHU Caen; 🇫🇷 Caen, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHI Créteil; 🇫🇷 Créteil, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Grenoble; 🇫🇷 La Tronche, France

AP-HP Hôpital Kremlin Bicêtre; 🇫🇷 le Kremlin Bicêtre, France

CHU Le Mans; 🇫🇷 Le Mans, France

CHU Limoges; 🇫🇷 Limoges, France

AP-HM Hôpital La Timone; 🇫🇷 Marseille, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Nancy Hôpital Brabois; 🇫🇷 Nancy, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Nice; 🇫🇷 Nice, France

CHU Orléans; 🇫🇷 Orléans, France

AP-HP Hôpital Armand Trousseau; 🇫🇷 Paris, France

AP-HP Hôpital Necker; 🇫🇷 Paris, France

AP-HP Hôpital Robert Debré; 🇫🇷 Paris, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Reims; 🇫🇷 Reims, France

CHU Rouen; 🇫🇷 Rouen, France

CHU Saint Etienne; 🇫🇷 Saint-Etienne, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Tours; 🇫🇷 Tours, France

CHU Fort de France; 🇲🇶 Fort-de-France, Martinique

CHU de Saint Denis de la Réunion; 🇷🇪 Saint Denis, Réunion

CHU de Lille Hôpital Jeanne de Flandre; 🇫🇷 Lille, Nord, France