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Recruiting NCT05995171

Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

Conditions: Esophageal Atresia

Sponsor: University Hospital, Lille

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Questionnaire
OTHER
Locations 33
France (31)
CHU Amiens
Amiens
NOT_YET_RECRUITING
Djamal-Dine DJEDDI, MD
CHU Angers
Angers
Françoise SCHMITT, MD
CHU Besançon
Besançon
NOT_YET_RECRUITING
CHU Bordeaux
Bordeaux
HLC Hôpital Mère Enfant
Bron
CHU Caen
Caen
CHU Clermont-Ferrand
Clermont-Ferrand
NOT_YET_RECRUITING
CHI Créteil
Créteil
CHU Dijon
Dijon
Raphaelle MAUDINAS, MD
CHU Grenoble
La Tronche
NOT_YET_RECRUITING
Catherine Jacquier, MD
AP-HP Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre
NOT_YET_RECRUITING
CHU Le Mans
Le Mans
NOT_YET_RECRUITING
CHU de Lille Hôpital Jeanne de Flandre
Lille , Nord
CHU Limoges
Limoges
NOT_YET_RECRUITING
AP-HM Hôpital La Timone
Marseille
CHU Montpellier
Montpellier
CHU Nancy Hôpital Brabois
Nancy
NOT_YET_RECRUITING
CHU Nantes
Nantes
CHU Nice
Nice
NOT_YET_RECRUITING
Jean-François LECOMPTE, MD
CHU Orléans
Orléans
NOT_YET_RECRUITING
AP-HP Hôpital Armand Trousseau
Paris
NOT_YET_RECRUITING
AP-HP Hôpital Necker
Paris
Véronique Rousseau, MD
AP-HP Hôpital Robert Debré
Paris
Arnaud Bonnard, MD, Pr
CHU Poitiers
Poitiers
CHU de Reims
Reims
NOT_YET_RECRUITING
CHU de Rennes
Rennes
Laure Bridoux-Henno, MD
CHU Rouen
Rouen
NOT_YET_RECRUITING
Clémentine Dumant, MD
CHU Saint Etienne
Saint-Etienne
NOT_YET_RECRUITING
Clara CREMILLIEUX, MD
CHU Strasbourg
Strasbourg
NOT_YET_RECRUITING
CHU Toulouse
Toulouse
NOT_YET_RECRUITING
Aurélie Le Mandat, MD
CHU Tours
Tours
NOT_YET_RECRUITING
Stéphanie Willot, MD
Martinique (1)
CHU Fort de France
Fort-de-France
Reunion (1)
CHU de Saint Denis de la Réunion
Saint-Denis
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
13 Years
Maximum age
14 Years
Healthy volunteers
No
Start date
14.11.2023
Completion date
14.11.2026
Registry ID
NCT05995171
Source
clinicaltrials.gov
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