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ClinicalTrials.gov ID

NCT05995171

Lead Sponsor

University Hospital, LilleOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

300Estimated

Last Update Posted

Apr 22, 2026Actual

Start Date

Nov 14, 2023Actual

Primary Completion Date

Nov 14, 2026Estimated

Completion Date

Nov 14, 2026Estimated

Official Title

Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

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.

• Esophageal Atresia

• Questionnaire

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

University Hospital, LilleOTHER

Collaborators

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

DRC@chru-lille.fr0320444145

DRC@chu-lille.fr0320444145

DRC@chru-lille.fr0320444145

DRC@chru-lille.fr0320444145

DRC@chru-lille.fr0320444145

DRC@churu-lille.fr0320444145

DRC@chru-lille.fr0320444145

DRC@chru-lille.fr0320444145

DRC@chru-lille.fr0320444145

DRC@chru-lille.fr0320444145

DRC@chru-lille.fr0320444145

DRC@chru-lille.fr0320444145