Long-term outcomes of adolescents with esophageal atresia
Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
This study is trying to learn about the long-term health of teenagers who were born with esophageal atresia by collecting medical data and samples to see how they are doing after their surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 13 Years to 14 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 33 sites (Lille, Nord and 32 other locations) |
| Trial ID | NCT05995171 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a prospective cohort of adolescents aged 13 and 14 who were born with esophageal atresia in France. It will involve collecting clinical and omic data, including a biobank of esophageal mucosa and plasma blood samples, to assess the long-term outcomes of this rare condition. The data will be analyzed using the France Cohortes information system to establish multi-omic profiles and understand the health issues that persist after surgical intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 13 or 14 who were born with esophageal atresia and have undergone the necessary surgical procedures.
Not a fit: Patients with chronic progressive diseases or those who do not meet the inclusion criteria for the study may not receive any benefit.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term health challenges faced by adolescents with esophageal atresia, potentially leading to improved management strategies.
How similar studies have performed: While there may be studies on esophageal atresia, this approach of creating a multi-omic profile in adolescents is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille, Nord and 32 other locations
- CHU de Lille Hôpital Jeanne de Flandre — Lille, Nord, France (Recruiting)
- CHU Amiens — Amiens, France (Not_yet_recruiting)
- CHU Angers — Angers, France (Recruiting)
- CHU Besançon — Besançon, France (Not_yet_recruiting)
- CHU Bordeaux — Bordeaux, France (Recruiting)
- HLC Hôpital Mère Enfant — Bron, France (Recruiting)
- CHU Caen — Caen, France (Recruiting)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
- CHI Créteil — Créteil, France (Recruiting)
- CHU Dijon — Dijon, France (Recruiting)
- CHU Grenoble — La Tronche, France (Not_yet_recruiting)
- AP-HP Hôpital Kremlin Bicêtre — Le Kremlin-Bicêtre, France (Not_yet_recruiting)
- CHU Le Mans — Le Mans, France (Not_yet_recruiting)
- CHU Limoges — Limoges, France (Not_yet_recruiting)
- AP-HM Hôpital La Timone — Marseille, France (Recruiting)
- CHU Montpellier — Montpellier, France (Recruiting)
- CHU Nancy Hôpital Brabois — Nancy, France (Not_yet_recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- CHU Nice — Nice, France (Not_yet_recruiting)
- CHU Orléans — Orléans, France (Not_yet_recruiting)
- AP-HP Hôpital Armand Trousseau — Paris, France (Not_yet_recruiting)
- AP-HP Hôpital Necker — Paris, France (Recruiting)
- AP-HP Hôpital Robert Debré — Paris, France (Recruiting)
- CHU Poitiers — Poitiers, France (Recruiting)
- CHU de Reims — Reims, France (Not_yet_recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
- CHU Rouen — Rouen, France (Not_yet_recruiting)
- CHU Saint Etienne — Saint-Etienne, France (Not_yet_recruiting)
- CHU Strasbourg — Strasbourg, France (Not_yet_recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
- CHU Tours — Tours, France (Not_yet_recruiting)
- CHU Fort de France — Fort-de-France, Martinique (Recruiting)
- CHU de Saint Denis de la Réunion — Saint-Denis, Reunion (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.