Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

Обзор

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.

Вмешательства

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

Первичные конечные точки

• prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia [Срок оценки: 13-14 years]

Вторичные конечные точки (5)

• Quality of life, nutritional status and respiratory complications [Срок оценки: 13-14 years]
• Omics and multi omics profiles in plasma [Срок оценки: 13-14 years]
• Factors associated with GERD [Срок оценки: Birth,1 year, 6 years and 13-14 years]
• Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsy [Срок оценки: 13-14 years]
• Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsy [Срок оценки: 13-14 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 31 центр

• CHU de Lille Hôpital Jeanne de Flandre — Lille
• CHU Amiens — Amiens
• CHU Angers — Angers
• CHU Besançon — Besançon
• CHU Bordeaux — Bordeaux
• HLC Hôpital Mère Enfant — Bron
• CHU Caen — Caen
• CHU Clermont-Ferrand — Clermont-Ferrand
• … и ещё 23 центра

Martinique · 1 центр

• CHU Fort de France — Fort-de-France

Reunion · 1 центр

• CHU de Saint Denis de la Réunion — Saint-Denis

Публикации

• Leroy M, Aumar M, Duhamel M, Dauchet L, Figeac M, Gaillard S, Hankard R, Labreuche J, Marot G, Reversat J, Armand V, Salzet M, Sfeir R, Vandel J, Gottrand F. Long-term outcome of oesophageal atresia in adolescence (TransEAsome): a national French cohort study protocol. BMJ Open. 2025 Jan 11;15(1):e086303. doi: 10.1136/bmjopen-2024-086303. PMID 39800411

Идентификаторы

NCT: NCT05995171 · 2022_0483

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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