Esophageal AtresiaTransEAsomeNCT05995171
Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
An observational study of Esophageal Atresia, run by University Hospital, Lille at 33 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 14 years
- Conditions the study is for
- Esophageal Atresia
- What is being tested?
- Questionnaire
- How many people
- 300 participants
- Where
- 33 sitesin 3 countries
- Study dates
- 14 Nov 2023to 14 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: children aged 13 to 14 born with oesophageal atresia
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
33 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 3 countries
France31 sites, 31 recruiting
- Not yet recruiting
CHU Amiens
Amiens
Djamal-Dine DJEDDI, MD, 0320444145, DRC@chru-lille.fr
Djamal-Dine DJEDDI, MD
- Recruiting
CHU Angers
Angers
Françoise SCHMITT, MD, 0320444145, DRC@chu-lille.fr
Françoise SCHMITT, MD
- Not yet recruiting
CHU Besançon
Besançon
Marlène CHOTARD, MD, 0320444145, DRC@chru-lille.fr
Marlène CHOTARD, MD
- Recruiting
CHU Bordeaux
Bordeaux
Raphael ENAUD, MD, 0320444145, DRC@chru-lille.fr
Raphael ENAUD, MD
- Recruiting
HLC Hôpital Mère Enfant
Bron
Nicolas Caron, MD, 0320444145, DRC@chru-lille.fr
Nicolas Caron, MD
- Recruiting
CHU Caen
Caen
Claire DUPONT, MD, 0320444145, DRC@chru-lille.fr
Claire Dupont, MD
- Not yet recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Corinne Borderon, MD, 0320444145, DRC@chru-lille.fr
Corinne Borderon, MD
- Recruiting
CHI Créteil
Créteil
Camille Jung, MD, 0320444145, DRC@chru-lille.fr
Camille Jung, MD
- Recruiting
CHU Dijon
Dijon
Raphaelle MAUDINAS, MD, 0320444145, DRC@churu-lille.fr
Raphaelle Maudinas, MD
- Not yet recruiting
CHU Grenoble
La Tronche
Catherine Jacquier, MD, 0320444145, DRC@chru-lille.fr
Catherine Jacquier, MD
- Not yet recruiting
AP-HP Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre
Virginie Fouquet, MD, 0320444145, DRC@chru-lille.fr
Virginie Fouquet, MD
- Not yet recruiting
CHU Le Mans
Le Mans
Cécile PELATAN, MD, 0320444145, DRC@chru-lille.fr
Cécile PELATAN, MD
- Recruiting
CHU de Lille Hôpital Jeanne de Flandre
Lille, Nord, 59000
Frédéric Gottrand, 0320444145, DRC@chu-lille.fr
Frédéric Gottrand, MD, PhD
- Not yet recruiting
CHU Limoges
Limoges
Audrey Nicolas, MD, 0320444145, DRC@chru-lille.fr
Audrey Nicolas, MD
- Recruiting
AP-HM Hôpital La Timone
Marseille
Nicoleta Panait, MD, 0320444145, DRC@chru-lille.fr
Nicoleta Panait, MD
- Recruiting
CHU Montpellier
Montpellier
Margot OLLIVIER, MD, 0320444145, DRC@chru-lille.fr
Margot Ollivier, MD
- Not yet recruiting
CHU Nancy Hôpital Brabois
Nancy
Julie Liénard, MD, 0320444145, DRC@chru-lille.fr
Julie Liénard, MD
- Recruiting
CHU Nantes
Nantes
Audrey GUINOT, MD, 0320444145, DRC@chru-lille.fr
Audrey Guinot, MD
- Not yet recruiting
CHU Nice
Nice
Jean-François LECOMPTE, MD, 0320444145, DRC@chru-lille.fr
Jean-François LECOMPTE, MD
- Not yet recruiting
CHU Orléans
Orléans
Myriam Arnould, MD, 0320444145, DRC@chru-lille.fr
Myriam Arnould, MD
- Not yet recruiting
AP-HP Hôpital Armand Trousseau
Paris
Julie LEMALE, MD, 0320444145, DRC@chru-lille.fr
Julie LEMALE, MD
- Recruiting
AP-HP Hôpital Necker
Paris
Véronique Rousseau, MD, 0320444145, DRC@chru-lille.fr
Véronique Rousseau, MD
- Recruiting
AP-HP Hôpital Robert Debré
Paris
Arnaud Bonnard, MD, Pr, 0320444145, DRC@chru-lille.fr
Arnaud Bonnard, MD, Pr
- Recruiting
CHU Poitiers
Poitiers
Diana POTOP, MD, 0320444145, DRC@chru-lille.fr
Diana POTOP, MD
- Not yet recruiting
CHU de Reims
Reims
Francesco LACONI, MD, 0320444145, DRC@chru-lille.fr
Francesco LACONI, MD
- Recruiting
CHU de Rennes
Rennes
Laure Bridoux-Henno, MD, 0320444145, DRC@chru-lille.fr
Laure BRIDOUX-HENNO, MD
- Not yet recruiting
CHU Rouen
Rouen
Clémentine Dumant, MD, 0320444145, DRC@chru-lille.fr
Clémentine Dumant, MD
- Not yet recruiting
CHU Saint Etienne
Saint-Etienne
Clara CREMILLIEUX, MD, 0320444145, DRC@chru-lille.fr
Clara Cremillieux, MD
- Not yet recruiting
CHU Strasbourg
Strasbourg
Isabelle Talon, MD, 0320444145, DRC@chru-lille.fr
Isabelle Talon, MD
- Not yet recruiting
CHU Toulouse
Toulouse
Aurélie Le Mandat, MD, 0320444145, DRC@chru-lille.fr
Aurélie Le Mandat, MD
- Not yet recruiting
CHU Tours
Tours
Stéphanie Willot, MD, 0320444145, DRC@chru-lille.fr
Aurélie Willot, MD
Martinique1 site, 1 recruiting
- Recruiting
CHU Fort de France
Fort-de-France
Ianis Cousin, MD, 0320444145, DRC@chu-lille.fr
Ianis Cousin, MD
Reunion1 site, 1 recruiting
- Not yet recruiting
CHU de Saint Denis de la Réunion
Saint-Denis
Gaulthier Foulon, MD, 0320444145, DRC@chru-lille.fr
Gaulthier Foulon, MD
About this study
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
- Esophageal Atresia
- Being tested
- Questionnaire
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL
| Study group | Role | What they receive |
|---|---|---|
| Esophageal atresia arm | Patient with esophageal atresia Receives: Other: Questionnaire | |
| control arm | Patient without esophageal atresia Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia
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]
Measured: 13-14 years
Secondary outcomes (5)
Quality of life, nutritional status and respiratory complications
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).
Measured: 13-14 years
Omics and multi omics profiles in plasma
Measured: 13-14 years
Factors associated with GERD
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).
Measured: Birth,1 year, 6 years and 13-14 years
Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsy
metabolites, proteins and methylation
Measured: 13-14 years
Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsy
metabolites, proteins and methylation
Measured: 13-14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start14 Nov 2023
- Primary completion14 Nov 2026 (estimated)
- Study completion14 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995171
- Sponsor's protocol ID
- 2022_0483
- Acronym
- TransEAsome
- Status last verified
- Apr 2026
- First submitted
- 31 Jul 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leroy M, Aumar M, Duhamel M, Dauchet L, Figeac M, Gaillard S, Hankard R, Labreuche J, Marot G, Reversat J, Armand V, Salzet M, Sfeir R, Vandel J, Gottrand F. Long-term outcome of oesophageal atresia in adolescence (TransEAsome): a national French cohort study protocol. BMJ Open. 2025 Jan 11;15(1):e086303. doi: 10.1136/bmjopen-2024-086303.
PubMed 39800411