Actively Recruiting

Age: 13Years - 14Years
All Genders
ID05995171

Long Term Outcome of Esophageal Atresia: Multi-Omic Profiles in Adolescents

Led by University Hospital, Lille · Updated on 2026-04-22

300

Participants Needed

33

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Lille

Lead Sponsor

I

Institut National de la Santé Et de la Recherche Médicale, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying adolescents aged 13 to 14 who were born with esophageal atresia, a birth defect where the esophagus is interrupted and ends in a dead end. Surgery is required soon after birth to restore esophagus continuity, but many children continue to experience health issues such as acid reflux, eating difficulties, breathing problems, and growth challenges throughout life. This study aims to assess the long-term outcomes and develop detailed molecular profiles of esophageal tissue and blood samples from this rare condition. The study includes two groups: adolescents with esophageal atresia and a control group without the condition. Participants undergo upper gastrointestinal endoscopy with biopsy sampling as part of their usual care. Quality of life questionnaires designed specifically for this research, including the Pediatric Quality of Life Inventory and EA-QoL, are used. Clinical and molecular data from tissue and blood samples will be analyzed together to understand disease impact and molecular changes. Data will be stored and shared through the France Cohortes platform. Participants will have their gastroesophageal reflux disease (GERD) status assessed along with measures of quality of life, nutrition, and respiratory health. Researchers will analyze molecular profiles from plasma and esophageal biopsies, and look at factors associated with GERD from birth through adolescence. Participation involves clinical data collection, questionnaires, and biological sampling during routine care. Data from this study will contribute to understanding the long-term effects of esophageal atresia and aid future research.

CONDITIONS

Brief Title

Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

Who Can Participate

Age: 13Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Born with esophageal atresia in France or French overseas territories
  • Surgery (anastomosis) performed to reconnect the esophagus
  • Included in the ReNaTo registry
  • Aged 13 or 14 during recruitment
  • Willing to comply with all study procedures and duration
  • Covered by social security
  • For blood sub-study: upper GI endoscopy with esophageal mucosal biopsy performed between ages 13 and 14 with consent given
  • For control group: upper GI endoscopy with esophageal mucosal biopsy performed between ages 10 and 14 for digestive symptoms ruling out organic disease
  • Normal endoscopy and histology for control group
  • No chronic progressive disease in control group
Not Eligible

You will not qualify if you...

  • Current or recent (within 3 months) participation in an interventional trial for esophageal atresia group
  • Parents refusing participation in either group
  • Histologically abnormal esophageal biopsy in control group
  • Known organic pathology in control group

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single timepoint at ages 13 to 14 years

Participants undergo upper GI endoscopy with esophageal mucosal biopsy and complete quality of life questionnaires to assess digestive health and multi-omic profiles.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 1 year following diagnostic evaluation

Participants are observed for long-term outcomes including gastroesophageal reflux disease prevalence, nutritional status, respiratory complications, and multi-omics profiles.

Follow-up assessments may occur depending on participant group

Trial Site Locations

Total: 33 locations

1

CHU de Lille Hôpital Jeanne de Flandre

Lille, Nord, France, 59000

Actively Recruiting

2

CHU Amiens

Amiens, France

Not Yet Recruiting

3

CHU Angers

Angers, France

Actively Recruiting

4

CHU Besançon

Besançon, France

Not Yet Recruiting

5

CHU Bordeaux

Bordeaux, France

Actively Recruiting

6

HLC Hôpital Mère Enfant

Bron, France

Actively Recruiting

7

CHU Caen

Caen, France

Actively Recruiting

8

CHU Clermont-Ferrand

Clermont-Ferrand, France

Not Yet Recruiting

9

CHI Créteil

Créteil, France

Actively Recruiting

10

CHU Dijon

Dijon, France

Actively Recruiting

11

CHU Grenoble

La Tronche, France

Not Yet Recruiting

12

AP-HP Hôpital Kremlin Bicêtre

Le Kremlin-Bicêtre, France

Not Yet Recruiting

13

CHU Le Mans

Le Mans, France

Not Yet Recruiting

14

CHU Limoges

Limoges, France

Not Yet Recruiting

15

AP-HM Hôpital La Timone

Marseille, France

Actively Recruiting

16

CHU Montpellier

Montpellier, France

Actively Recruiting

17

CHU Nancy Hôpital Brabois

Nancy, France

Not Yet Recruiting

18

CHU Nantes

Nantes, France

Actively Recruiting

19

CHU Nice

Nice, France

Not Yet Recruiting

20

CHU Orléans

Orléans, France

Not Yet Recruiting

21

AP-HP Hôpital Armand Trousseau

Paris, France

Not Yet Recruiting

22

AP-HP Hôpital Necker

Paris, France

Actively Recruiting

23

AP-HP Hôpital Robert Debré

Paris, France

Actively Recruiting

24

CHU Poitiers

Poitiers, France

Actively Recruiting

25

CHU de Reims

Reims, France

Not Yet Recruiting

26

CHU de Rennes

Rennes, France

Actively Recruiting

27

CHU Rouen

Rouen, France

Not Yet Recruiting

28

CHU Saint Etienne

Saint-Etienne, France

Not Yet Recruiting

29

CHU Strasbourg

Strasbourg, France

Not Yet Recruiting

30

CHU Toulouse

Toulouse, France

Not Yet Recruiting

31

CHU Tours

Tours, France

Not Yet Recruiting

32

CHU Fort de France

Fort-de-France, Martinique

Actively Recruiting

33

CHU de Saint Denis de la Réunion

Saint-Denis, Reunion

Not Yet Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Long-term outcome of oesophageal atresia in adolescence (TransEAsome): a national French cohort study protocol.

Mélanie Leroy, Madeleine Aumar, Marie Duhamel...

https://pubmed.ncbi.nlm.nih.gov/39800411