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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esophageal atresia arm | Patient with esophageal atresia |
| |
| control arm | Patient without esophageal atresia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL |
|
| Measure | Description | Time Frame |
|---|---|---|
| prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia | GERD = [pH/impedance-metry demonstrating pathological GERD and/or if lesions of peptic esophagitis are observed at an endoscopy in the year preceding the visit or if the child has a history of complicated GERD leading to anti-reflux surgery] | 13-14 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life, nutritional status and respiratory complications | Quality of life= EA-QoL and PedsQL The quality of life of patients in adolescence will be assessed by means of the following quality of life scales at the age of 13-14 years: PedsQL (13) and EA-QoL (11) by both the patient and a parent. Scale scores will be calculated in accordance with the authors' instructions.
|
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Inclusion Criteria:
For the blood sub-study :
For the control arm:
Exclusion Criteria:
For the control arm :
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children aged 13 to 14 born with oesophageal atresia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille Hôpital Jeanne de Flandre | Recruiting | Lille | Nord | 59000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39800411 | Result | 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. |
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| 13-14 years |
| Omics and multi omics profiles in plasma | 13-14 years |
| Factors associated with GERD | It will be determined from patient characteristics at birth, 1 year, 6 years and 13-14 years (ante-natal data, vital signs, presence of associated malformations, type of atresia, surgical procedures performed, surgical/digestive/respiratory/neuro-orthopaedic complications, type of diet and schooling). | Birth,1 year, 6 years and 13-14 years |
| Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsy | metabolites, proteins and methylation | 13-14 years |
| Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsy | metabolites, proteins and methylation | 13-14 years |
| CHU Amiens | Not yet recruiting | Amiens | France |
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| CHU Angers | Recruiting | Angers | France |
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| CHU Besançon | Not yet recruiting | Besançon | France |
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| CHU Bordeaux | Recruiting | Bordeaux | France |
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| HLC Hôpital Mère Enfant | Recruiting | Bron | France |
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| CHU Caen | Recruiting | Caen | France |
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| CHU Clermont-Ferrand | Not yet recruiting | Clermont-Ferrand | France |
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| CHI Créteil | Recruiting | Créteil | France |
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| CHU Dijon | Recruiting | Dijon | France |
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| CHU Grenoble | Not yet recruiting | La Tronche | France |
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| AP-HP Hôpital Kremlin Bicêtre | Not yet recruiting | Le Kremlin-Bicêtre | France |
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| CHU Le Mans | Not yet recruiting | Le Mans | France |
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| CHU Limoges | Not yet recruiting | Limoges | France |
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| AP-HM Hôpital La Timone | Recruiting | Marseille | France |
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| CHU Montpellier | Recruiting | Montpellier | France |
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| CHU Nancy Hôpital Brabois | Not yet recruiting | Nancy | France |
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| CHU Nantes | Recruiting | Nantes | France |
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| CHU Nice | Not yet recruiting | Nice | France |
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| CHU Orléans | Not yet recruiting | Orléans | France |
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| AP-HP Hôpital Armand Trousseau | Not yet recruiting | Paris | France |
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| AP-HP Hôpital Necker | Recruiting | Paris | France |
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| AP-HP Hôpital Robert Debré | Recruiting | Paris | France |
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| CHU Poitiers | Recruiting | Poitiers | France |
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| CHU de Reims | Not yet recruiting | Reims | France |
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| CHU de Rennes | Recruiting | Rennes | France |
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| CHU Rouen | Not yet recruiting | Rouen | France |
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| CHU Saint Etienne | Not yet recruiting | Saint-Etienne | France |
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| CHU Strasbourg | Not yet recruiting | Strasbourg | France |
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| CHU Toulouse | Not yet recruiting | Toulouse | France |
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| CHU Tours | Not yet recruiting | Tours | France |
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| CHU Fort de France | Recruiting | Fort-de-France | Martinique |
|
| CHU de Saint Denis de la Réunion | Not yet recruiting | Saint-Denis | Reunion |
|
| ID | Term |
|---|---|
| D004933 | Esophageal Atresia |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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