Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence (NCT05995171) | Clinical Trial Compass
RecruitingNot Applicable
Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
France, Martinique, Reunion300 participantsStarted 2023-11-14
Plain-language 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.
Who can participate
Age range
13 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia