RecruitingNCT05995171

Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence


Sponsor

University Hospital, Lille

Enrollment

300 participants

Start Date

Nov 14, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 13 YearsMax Age: 14 Years

Inclusion Criteria15

  • 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 Criteria7

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERQuestionnaire

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


Locations(33)

CHU de Lille Hôpital Jeanne de Flandre

Lille, Nord, France

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 Reims

Reims, France

CHU de Rennes

Rennes, 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, Reunion

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05995171


Related Trials