FReSH-43727-en
Long-Term Outcomes of Esophageal Atresia: Transomic Profiles in Adolescence
TransEAsome
| Name | Country code |
|---|---|
| France | fr |
Esophageal atresia (EA), a congenital malformation of the esophagus present at birth, is characterized by a disruption in the continuity of the esophagus, which ends in a blind pouch. Food or saliva cannot pass into the stomach. It affects an average of 150 births per year in France, making it a rare condition.
It is therefore necessary to perform surgery to restore continuity of the esophagus. Although this procedure allows the vast majority of children to survive the neonatal period, health problems such as gastroesophageal reflux, difficulty eating, respiratory problems, and growth issues may persist throughout their lives.
Project Objectives
The goal of the project is to establish a prospective cohort of 13- and 14-year-old adolescents, nested within the national esophageal atresia registry. In addition to clinical data, a biobank of esophageal mucosal and plasma samples will be established.
Once the clinical data have been collected and the omics data (derived from the analysis of biological samples from the biobank) have been generated, they will be analyzed by the project partners to assess the long-term course of EA and establish multi-omics profiles.
['Clinical data','Biological data','Socio-demographic data','Economic data','Other']
Individus
| Topic | Vocabulary |
|---|---|
| Gastroenterology | health theme |
| Paediatrics | health theme |
| Atresia of oesophagus | cim-11 |
| Atresia of oesophagus without fistula | cim-11 |
| Atresia of oesophagus with tracheo-oesophageal fistula | cim-11 |
| Long gap oesophageal atresia | cim-11 |
| Atresia of oesophagus with oesophagobronchial fistula | cim-11 |
| Atresia of oesophagus with fistula between trachea and lower oesophageal pouch | cim-11 |
| Atresia of oesophagus with fistula between trachea and upper oesophageal pouch | cim-11 |
| Atresia of oesophagus with fistula between trachea and oesophageal pouch | cim-11 |
| Socio-demographic and economic determinants | health determinant |
| Socio-demographic and economic determinants: Gender | health determinant |
| Socio-demographic and economic determinants: Age | health determinant |
| Healthcare system determinants | health determinant |
| Healthcare system determinants: Use of care | health determinant |
| Behavioral determinants | health determinant |
| Behavioral determinants: Physical activity | health determinant |
| Behavioral determinants: Hygiene | health determinant |
| Biological determinants | health determinant |
| Biological determinants: Sex | health determinant |
| Other | health determinant |
| proteins, methylation, microRNA | other determinant |
['Auvergne Rhône-Alpes','Bourgogne Franche-Comté','Bretagne','Centre-Val de Loire','Corse','Grand Est','Guadeloupe','Hauts-de-France','Ile-de-France','La Réunion','Martinique','Normandie','Nouvelle-Aquitaine','Occitanie','Pays de la Loire','Provence - Alpes - Côte d'Azur']
{
"level_sex_clusion_I": [
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D005260"
},
"value": "Female"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D008297"
},
"value": "Male"
}
],
"level_age_clusion_I": [
{
"concept": {
"vocab": "MeSH",
"vocabURI": ""
},
"value": "Prenatal"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D007231"
},
"value": "Infant, Newborn (birth to 28 days)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D007223"
},
"value": "Infant (28 days to 2 years)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D002648"
},
"value": "Child (6 to 12 years)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D000293"
},
"value": "Adolescent (13 to 18 years)"
}
],
"level_type_clusion_I": "Patients population",
"level_type_clusion_other": "",
"clusion_I": "For the EA group:\r\n- Born with esophageal atresia (EA) in France or in the French overseas departments and territories (DOM\/TOM)\r\n- Esophageal anastomosis performed\r\n- Must be 13 or 14 years old during the recruitment period (2023–2026)\r\n- Enrollment in the Renato Registry\r\n- Patient covered by social security\r\n- A patient willing to comply with all study procedures and to participate for the duration of the study\r\n\r\nFor the blood substudy:\r\n- Upper gastrointestinal endoscopy performed as part of medical care between the ages of 10 and 14, with a biopsy of the esophageal mucosa\r\n- Patient who has provided written consent to participate in the study (or in the ancillary study, if applicable, for the centers in Lille, Paris Necker, Paris Robert Debré, Lyon, Marseille, and Grenoble)\r\n\r\n\r\nFor the control group:\r\n- Upper gastrointestinal endoscopy performed between the ages of 10 and 14, with a biopsy of the esophageal mucosa\r\n- Upper gastrointestinal endoscopy performed as part of the management of chronic or acute gastrointestinal symptoms to rule out an organic cause (peptic esophagitis, gastric esophagitis, eosinophilic esophagitis or ulcer)\r\n- Normal endoscopy and histology\r\n- No concurrent progressive chronic disease",
"clusion_E": "Exclusion Criteria\r\n\r\nFor the EA group:\r\n- Concurrent participation in an interventional trial as well as within 3\r\nthe month prior to inclusion\r\n- Parents who refuse to participate in the study\r\n\r\nFor the control group:\r\n- Esophageal biopsy with histologically abnormal findings\r\n- Parents who refuse to participate in the study\r\n- Child with a known organic condition"
}
| Name |
|---|
| Frédéric;GOTTRAND |
| Name | Role |
|---|---|
| CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU) | sponsor |
| Name |
|---|
| AGENCE NATIONALE DE LA RECHERCHE (ANR) |
| Name |
|---|
| Martin;FIGEAC |
| UNIVERSITE DE LILLE |
| Michel;SALZET |
| INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) |
| Jimmy;VANDEL |
| UNIVERSITE DE LILLE |
| Régis;HANKARD |
| CENTRE HOSPITALIER UNIVERSITAIRE D ORLEANS (CHUO) |
| the CRACMO network |
| Agency name |
|---|
| CNIL |
| CPP |
['Disease and death registry']
['{"concept":{"vocab":"CESSDA","vocabURI":"TotalUniverseCompleteEnumeration"},"value":"Complete enumeration (including consecutive recruitment)"}']
Observational Study
| Start | End |
|---|---|
| 2024-08-30 | 2026-10-10 |
Other
Once
| Name | |
|---|---|
| Mélanie;LEROY | melanie.leroy@chu-lille.fr |
{"extLink":{"title":"COAR","uri":""},"value":"To be defined"}
| Name | |
|---|---|
| Mélanie;LEROY | melanie.leroy@chu-lille.fr |
| Martin;FIGEAC | martin.figeac@univ-lille.fr |
| Michel;SALZET | michel.salzet@inserm.fr |
| Jimmy;VANDEL | jimmy.vandel@univ-lille.fr |
| Régis;HANKARD | regis.hankard@chu-orleans.fr |
FReSH-43727-en
| Name |
|---|
| Mélanie LEROY |