NCT05995171 Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
| NCT ID | NCT05995171 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Esophageal Atresia |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-11-14 |
| Primary Completion | 2026-11-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-11-14 with a primary completion date of 2026-11-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05995171 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 14 Years, studying Esophageal Atresia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05995171 currently recruiting?
Yes, NCT05995171 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Lille to inquire about joining.
Where is the NCT05995171 trial being conducted?
This trial is being conducted at Lille, France, Amiens, France, Angers, France, Besançon, France and 11 additional locations.
Who is sponsoring the NCT05995171 clinical trial?
NCT05995171 is sponsored by University Hospital, Lille. The trial plans to enroll 300 participants.