Trials / Recruiting
RecruitingNCT05995171
Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- All
- Age
- 13 Years – 14 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Questionnaire | Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL |
Timeline
- Start date
- 2023-11-14
- Primary completion
- 2026-11-14
- Completion
- 2026-11-14
- First posted
- 2023-08-16
- Last updated
- 2026-02-20
Locations
33 sites across 3 countries: France, Martinique, Reunion
Source: ClinicalTrials.gov record NCT05995171. Inclusion in this directory is not an endorsement.