Status:
RECRUITING
Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Esophageal Atresia
Eligibility:
All Genders
13-14 years
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: Fim...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 14 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05995171
Start Date
November 14 2023
End Date
November 14 2026
Last Update
September 26 2024
Active Locations (33)
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1
CHU de Lille Hôpital Jeanne de Flandre
Lille, Nord, France, 59000
2
CHU Amiens
Amiens, France
3
CHU Angers
Angers, France
4
CHU Besançon
Besançon, France