Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

Last updated: September 24, 2024
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Treatment

Questionnaire

Clinical Study ID

NCT05995171
2022_0483
  • Ages 13-14
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • For the oesophageal atresia group :

  • Born with oesophageal atresia (EA) in France or in French overseas departments andterritories

  • 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 withesophageal 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 withoesophageal mucosal biopsy sampling

  • Upper GI endoscopy performed as part of care for chronic or acute digestive signs torule out organic etiology (peptic esophagitis, gastric esophagitis, eosinophilicesophagitis or ulcer)

  • Normal endoscopy and histology

  • No chronic progressive disease

Exclusion

Exclusion Criteria:

  • For the oesophagal atresia arm :

  • Concurrent participation in an interventional trial and in the 3 months prior toinclusion

  • 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

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Questionnaire
Phase:
Study Start date:
November 14, 2023
Estimated Completion Date:
November 14, 2026

Connect with a study center

  • CHU de Lille Hôpital Jeanne de Flandre

    Lille, Nord 59000
    France

    Active - Recruiting

  • CHU Amiens

    Amiens,
    France

    Site Not Available

  • CHU Angers

    Angers,
    France

    Active - Recruiting

  • CHU Besançon

    Besançon,
    France

    Site Not Available

  • CHU Bordeaux

    Bordeaux,
    France

    Active - Recruiting

  • HLC Hôpital Mère Enfant

    Bron,
    France

    Active - Recruiting

  • CHU Caen

    Caen,
    France

    Active - Recruiting

  • CHU Clermont-Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • CHI Créteil

    Créteil,
    France

    Active - Recruiting

  • CHU Dijon

    Dijon,
    France

    Active - Recruiting

  • CHU Grenoble

    La Tronche,
    France

    Site Not Available

  • CHU Le Mans

    Le Mans,
    France

    Site Not Available

  • CHU Limoges

    Limoges,
    France

    Site Not Available

  • AP-HM Hôpital La Timone

    Marseille,
    France

    Active - Recruiting

  • CHU Montpellier

    Montpellier,
    France

    Active - Recruiting

  • CHU Nancy Hôpital Brabois

    Nancy,
    France

    Site Not Available

  • CHU Nantes

    Nantes,
    France

    Active - Recruiting

  • CHU Nice

    Nice,
    France

    Site Not Available

  • CHU Orléans

    Orléans,
    France

    Site Not Available

  • AP-HP Hôpital Armand Trousseau

    Paris,
    France

    Site Not Available

  • AP-HP Hôpital Necker

    Paris,
    France

    Active - Recruiting

  • AP-HP Hôpital Robert Debré

    Paris,
    France

    Active - Recruiting

  • CHU Poitiers

    Poitiers,
    France

    Active - Recruiting

  • CHU de Reims

    Reims,
    France

    Site Not Available

  • CHU de Rennes

    Rennes,
    France

    Active - Recruiting

  • CHU Rouen

    Rouen,
    France

    Site Not Available

  • CHU Saint Etienne

    Saint-Etienne,
    France

    Site Not Available

  • CHU Strasbourg

    Strasbourg,
    France

    Site Not Available

  • CHU Toulouse

    Toulouse,
    France

    Site Not Available

  • CHU Tours

    Tours,
    France

    Site Not Available

  • AP-HP Hôpital Kremlin Bicêtre

    le Kremlin Bicêtre,
    France

    Site Not Available

  • CHU Fort de France

    Fort-de-France,
    Martinique

    Active - Recruiting

  • CHU de Saint Denis de la Réunion

    Saint Denis,
    Réunion

    Site Not Available

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