Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

NCT05995171 | Recruiting

• 1 other identifier: 2022_0483
• Study Type: observational
• Target: 300
• Locations: 3 countries
• Sites: 33

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.

Conditions

Esophageal Atresia

Outcome Measures

Primary Outcomes (1)

• prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia

  GERD = \[pH/impedance-metry demonstrating pathological GERD and/or if lesions of peptic esophagitis are observed at an endoscopy in the year preceding the visit or if the child has a history of complicated GERD leading to anti-reflux surgery\]

  13-14 years

Secondary Outcomes (5)

• Quality of life, nutritional status and respiratory complications

  13-14 years

• Omics and multi omics profiles in plasma

  13-14 years

• Factors associated with GERD

  Birth,1 year, 6 years and 13-14 years

• Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsy

  13-14 years

• Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsy

  13-14 years

Study Arms (2)

Esophageal atresia arm

Patient with esophageal atresia

Other: Questionnaire

control arm

Patient without esophageal atresia

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Esophageal atresia arm; control arm

Eligibility Criteria

• Age: 13 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children aged 13 to 14 born with oesophageal atresia

You may qualify if:

• 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

You may not qualify if:

• For the oesophagal atresia arm :
• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• University Hospital, Lille: lead

Study Sites (33)

CHU de Lille Hôpital Jeanne de Flandre

Lille, Nord, 59000, France

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

Related Publications (1)

• Leroy M, Aumar M, Duhamel M, Dauchet L, Figeac M, Gaillard S, Hankard R, Labreuche J, Marot G, Reversat J, Armand V, Salzet M, Sfeir R, Vandel J, Gottrand F. Long-term outcome of oesophageal atresia in adolescence (TransEAsome): a national French cohort study protocol. BMJ Open. 2025 Jan 11;15(1):e086303. doi: 10.1136/bmjopen-2024-086303.

  PMID: 39800411 RESULT

MeSH Terms

Conditions

Esophageal Atresia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 16, 2023
• Study Start: November 14, 2023
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): November 14, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1); MA (1); FR (31)