Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

Esophageal Atresia Clinical Trial

— TransEAsome  

Official title:

Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995171
• Other study ID #: 2022_0483
• Status: Recruiting
• Start date: November 14, 2023
• Est. completion date: November 14, 2026

Study information

• Verified date: February 2024
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 14, 2026
• Est. primary completion date: November 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 14 Years

Eligibility

Inclusion Criteria:

• For the oesophagal atresia group :
• Born with oesophageal atresia (AO) in France or in French overseas departments and territories
• Operated at birth for an AO
• Aged 13 or 14 during the recruitment period
• Patient willing to comply with all study procedures and duration

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:

• Aged 13 or 14 during the recruitment period
• 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

Related Conditions & MeSH terms

• Esophageal Atresia

Intervention

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

Locations

Country	Name	City	State
France	CHU de Lille Hôpital Jeanne de Flandre	Lille	Nord

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	the prevalence of GERD at 13-14 years of age	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
Secondary	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.; Nutritional status will be assessed by weight and height, and by calculating the weight/height z-score and BMI z-score using the World Health Organisation growth curves as a reference (14).; Frequency of respiratory complications, assessed during clinical examination (hacking cough during infections, chronic cough, asthma, exertional symptoms (cough, dyspnoea), atopy, wheezing and/or stridor/corniness).	13-14 years
Secondary	Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsie	metabolites, proteins and methylation	13-14 years
Secondary	Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsie	metabolites, proteins and methylation	13-14 years
Secondary	Omics and multi omics profiles in plasma		13-14 years