Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
NCT ID: NCT05995171
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-11-14
2026-11-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Esophageal atresia arm
Patient with esophageal atresia
Questionnaire
Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL
control arm
Patient without esophageal atresia
Questionnaire
Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL
Interventions
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Questionnaire
Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
13 Years
14 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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Locations
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CHU de Lille Hôpital Jeanne de Flandre
Lille, Nord, France
CHU Amiens
Amiens, , France
CHU Angers
Angers, , France
CHU Besançon
Besançon, , France
CHU Bordeaux
Bordeaux, , France
HLC Hôpital Mère Enfant
Bron, , France
CHU Caen
Caen, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
CHI Créteil
Créteil, , France
CHU Dijon
Dijon, , France
CHU Grenoble
La Tronche, , France
AP-HP Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre, , France
CHU Le Mans
Le Mans, , France
CHU Limoges
Limoges, , France
AP-HM Hôpital La Timone
Marseille, , France
CHU Montpellier
Montpellier, , France
CHU Nancy Hôpital Brabois
Nancy, , France
CHU Nantes
Nantes, , France
CHU Nice
Nice, , France
CHU Orléans
Orléans, , France
AP-HP Hôpital Armand Trousseau
Paris, , France
AP-HP Hôpital Necker
Paris, , France
AP-HP Hôpital Robert Debré
Paris, , France
CHU Poitiers
Poitiers, , France
CHU de Reims
Reims, , France
CHU de Rennes
Rennes, , France
CHU Rouen
Rouen, , France
CHU Saint Etienne
Saint-Etienne, , France
CHU Strasbourg
Strasbourg, , France
CHU Toulouse
Toulouse, , France
CHU Tours
Tours, , France
CHU Fort de France
Fort-de-France, , Martinique
CHU de Saint Denis de la Réunion
Saint-Denis, , Reunion
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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2022_0483
Identifier Type: -
Identifier Source: org_study_id
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