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

April 21, 2026 updated by: University Hospital, Lille

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • CHU Amiens
        • Contact:
        • Principal Investigator:
          • Djamal-Dine DJEDDI, MD
      • Angers, France
        • Recruiting
        • CHU Angers
        • Contact:
        • Principal Investigator:
          • Françoise SCHMITT, MD
      • Besançon, France
        • Not yet recruiting
        • CHU Besancon
        • Contact:
        • Principal Investigator:
          • Marlène CHOTARD, MD
      • Bordeaux, France
        • Recruiting
        • CHU Bordeaux
        • Principal Investigator:
          • Raphaël ENAUD, MD
        • Contact:
      • Bron, France
        • Recruiting
        • HLC Hôpital Mère Enfant
        • Contact:
        • Principal Investigator:
          • Nicolas Caron, MD
      • Caen, France
        • Recruiting
        • CHU Caen
        • Contact:
        • Principal Investigator:
          • Claire Dupont, MD
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Chu Clermont-Ferrand
        • Contact:
        • Principal Investigator:
          • Corinne Borderon, MD
      • Créteil, France
        • Recruiting
        • CHi Creteil
        • Contact:
        • Principal Investigator:
          • Camille Jung, MD
      • Dijon, France
        • Recruiting
        • CHU Dijon
        • Contact:
        • Principal Investigator:
          • Raphaelle Maudinas, MD
      • La Tronche, France
        • Not yet recruiting
        • CHU Grenoble
        • Contact:
        • Principal Investigator:
          • Catherine Jacquier, MD
      • Le Kremlin-Bicêtre, France
        • Not yet recruiting
        • AP-HP Hôpital Kremlin Bicetre
        • Contact:
        • Principal Investigator:
          • Virginie Fouquet, MD
      • Le Mans, France
        • Not yet recruiting
        • CHU Le Mans
        • Contact:
        • Principal Investigator:
          • Cécile PELATAN, MD
      • Limoges, France
        • Not yet recruiting
        • CHU Limoges
        • Contact:
        • Principal Investigator:
          • Audrey Nicolas, MD
      • Marseille, France
        • Recruiting
        • AP-HM Hopital La Timone
        • Contact:
        • Principal Investigator:
          • Nicoleta Panait, MD
      • Montpellier, France
        • Recruiting
        • CHU Montpellier
        • Contact:
        • Principal Investigator:
          • Margot Ollivier, MD
      • Nancy, France
        • Not yet recruiting
        • Chu Nancy Hopital Brabois
        • Contact:
        • Principal Investigator:
          • Julie Liénard, MD
      • Nantes, France
        • Recruiting
        • CHU Nantes
        • Contact:
        • Principal Investigator:
          • Audrey Guinot, MD
      • Nice, France
        • Not yet recruiting
        • CHU Nice
        • Contact:
        • Principal Investigator:
          • Jean-François LECOMPTE, MD
      • Orléans, France
        • Not yet recruiting
        • Chu Orleans
        • Contact:
        • Principal Investigator:
          • Myriam Arnould, MD
      • Paris, France
        • Not yet recruiting
        • AP-HP Hôpital Armand Trousseau
        • Contact:
        • Principal Investigator:
          • Julie LEMALE, MD
      • Paris, France
        • Recruiting
        • AP-HP Hôpital Necker
        • Contact:
        • Principal Investigator:
          • Véronique Rousseau, MD
      • Paris, France
        • Recruiting
        • AP-HP Hôpital Robert Debré
        • Contact:
        • Principal Investigator:
          • Arnaud Bonnard, MD, Pr
      • Poitiers, France
        • Recruiting
        • CHU Poitiers
        • Contact:
        • Principal Investigator:
          • Diana POTOP, MD
      • Reims, France
        • Not yet recruiting
        • CHU de Reims
        • Contact:
        • Principal Investigator:
          • Francesco LACONI, MD
      • Rennes, France
        • Recruiting
        • CHU de Rennes
        • Contact:
        • Principal Investigator:
          • Laure BRIDOUX-HENNO, MD
      • Rouen, France
        • Not yet recruiting
        • CHU Rouen
        • Contact:
        • Principal Investigator:
          • Clémentine Dumant, MD
      • Saint-Etienne, France
        • Not yet recruiting
        • CHU Saint Etienne
        • Contact:
        • Principal Investigator:
          • Clara Cremillieux, MD
      • Strasbourg, France
        • Not yet recruiting
        • CHU Strasbourg
        • Principal Investigator:
          • Isabelle Talon, MD
        • Contact:
      • Toulouse, France
        • Not yet recruiting
        • CHU Toulouse
        • Contact:
        • Principal Investigator:
          • Aurélie Le Mandat, MD
      • Tours, France
        • Not yet recruiting
        • CHU Tours
        • Contact:
        • Principal Investigator:
          • Aurélie Willot, MD
    • Nord
      • Lille, Nord, France, 59000
        • Recruiting
        • CHU de Lille Hôpital Jeanne de Flandre
        • Contact:
        • Principal Investigator:
          • Frédéric Gottrand, MD, PhD
  • Martinique
      • Fort-de-France, Martinique
        • Recruiting
        • CHU Fort de France
        • Contact:
        • Principal Investigator:
          • Ianis Cousin, MD
  • Reunion
      • Saint-Denis, Reunion
        • Not yet recruiting
        • CHU de Saint Denis de la Réunion
        • Contact:
        • Principal Investigator:
          • Gaulthier Foulon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children aged 13 to 14 born with oesophageal atresia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Esophageal atresia arm
Patient with esophageal atresia
Other: Questionnaire
Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL
control arm
Patient without esophageal atresia
Other: Questionnaire
Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia
Time Frame: 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]
13-14 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life, nutritional status and respiratory complications
Time Frame: 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).
13-14 years
Omics and multi omics profiles in plasma
Time Frame: 13-14 years
13-14 years
Factors associated with GERD
Time Frame: 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).
Birth,1 year, 6 years and 13-14 years
Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsy
Time Frame: 13-14 years
metabolites, proteins and methylation
13-14 years
Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsy
Time Frame: 13-14 years
metabolites, proteins and methylation
13-14 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

November 14, 2026

Study Completion (Estimated)

November 14, 2026

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022_0483

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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