Clinical trial NCT05995171: Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
Official title: Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Atresia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2023-08-16
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children aged 13 to 14 born with oesophageal atresia

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.


Eligibility criteria: 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

Primary outcomes:
measure: prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia
timeFrame: 13-14 years
Secondary outcomes:
measure: Quality of life, nutritional status and respiratory complications
timeFrame: 13-14 years
measure: Omics and multi omics profiles in plasma
timeFrame: 13-14 years
measure: Factors associated with GERD
timeFrame: Birth,1 year, 6 years and 13-14 years
measure: Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsy
timeFrame: 13-14 years
measure: Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsy
timeFrame: 13-14 years
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille Hôpital Jeanne de Flandre
state: Nord
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Bron
country: France
facility: HLC Hôpital Mère Enfant
city: Caen
country: France
facility: CHU Caen
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Créteil
country: France
facility: CHI Créteil
city: Dijon
country: France
facility: CHU Dijon
city: La Tronche
country: France
facility: CHU Grenoble
city: le Kremlin Bicêtre
country: France
facility: AP-HP Hôpital Kremlin Bicêtre
city: Le Mans
country: France
facility: CHU Le Mans
city: Limoges
country: France
facility: CHU Limoges
city: Marseille
country: France
facility: AP-HM Hôpital La Timone
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU Nancy Hôpital Brabois
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Orléans
country: France
facility: CHU Orléans
city: Paris
country: France
facility: AP-HP Hôpital Armand Trousseau
city: Paris
country: France
facility: AP-HP Hôpital Necker
city: Paris
country: France
facility: AP-HP Hôpital Robert Debré
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Etienne
country: France
facility: CHU Saint Etienne
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
city: Fort-de-France
country: Martinique
facility: CHU Fort de France
city: Saint Denis
country: Réunion
facility: CHU de Saint Denis de la Réunion
Study officials:
References: