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NCT Number: NCT05995171

Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

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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Key information

Conditions

Esophageal Atresia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases

Age range

13 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Lille Hôpital Jeanne de Flandre, Lille, Nord, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia

    Time frame: 13-14 years

    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]

Secondary outcomes

  1. Quality of life, nutritional status and respiratory complications

    Time frame: 13-14 years

    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).

  2. Omics and multi omics profiles in plasma

    Time frame: 13-14 years

  3. Factors associated with GERD

    Time frame: Birth,1 year, 6 years and 13-14 years

    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).

  4. Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsy

    Time frame: 13-14 years

    metabolites, proteins and methylation

  5. Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsy

    Time frame: 13-14 years

    metabolites, proteins and methylation

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: TransEAsome

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2023
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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