Back to resultsMolecular Signatures of Esophageal Atresia
Primary Purpose
Esophageal Atresia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Esophageal biopsy collection during anastomosis
Sponsored by
About this trial
This is an interventional basic science trial for Esophageal Atresia focused on measuring esophageal atresia, epigenetic, proteomics, metabolomics
Eligibility Criteria
Inclusion Criteria: Anastomosis group : Born with esophageal atresia Anastomosis performed in Lille hospital Parents consent - Control group : Born with esophageal atresia Exclusion Criteria: Both groups : Parents refusing to participate in the study
Sites / Locations
- CHU LilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Anastomosis group
Control group
Arm Description
Esophageal biopsies collected during the anastomosis for the patient with esophageal atresia
Esophageal biopsies collected during a standard care endoscopy for patient with esophageal atresia during the first year of life
Outcomes
Primary Outcome Measures
Comparison of the mRNA expression from esophageal biopsies between long and short term storage
Transcriptomic profiles will be generated by the identification of mRNA and miRNA expression by 3'RNA-seq and sRNA-seq technologies. Differential expression between long and short term storage will be performed.[exploratory and untargeted analysis]
Comparison of the metabolites identification from esophageal biopsies between long and short term storage
Metabolomic profiles will be generated (untargeted analysis that will include mnulmerous lipids, amino-acids, ...). Differential expression between long and short term storage will be performed. [exploratory and untargeted analysis]
Secondary Outcome Measures
Full Information
NCT ID
NCT06073158
First Posted
June 26, 2023
Last Updated
October 12, 2023
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT06073158
Brief Title
Molecular Signatures of Esophageal Atresia
Official Title
Oesomics Anastomose Molecular Signatures of Esophageal Atresia Comparison of Biopsies Taken During the First Year of Life With Those Taken During Anastomosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2023 (Actual)
Primary Completion Date
June 23, 2024 (Anticipated)
Study Completion Date
June 23, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although several studies have revealed signaling pathways as well as genes potentially involved in the development of esophageal atresia (EA), our understanding of the pathophysiology of EA lags behind improvements in the surgical and clinical care of patients born with this anomaly. However, a causative genetic abnormality can be identified in less than 10% of patients, even using more recent next-generation sequencing techniques. As most cases of EA associated with tracheoesophageal fistula (TOF) are sporadic, and the familial recurrence rate is low (1%), this suggests that epigenetic and environmental factors also contribute to the disease. Further investigations are needed to better understand the mechanisms underlying EA. That information can come from the oesophageal biopsies that are collected in routine care and long-term storage at the hospital. However, the impact of the length of the storage is still unknown.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Atresia
Keywords
esophageal atresia, epigenetic, proteomics, metabolomics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anastomosis group
Arm Type
Other
Arm Description
Esophageal biopsies collected during the anastomosis for the patient with esophageal atresia
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Esophageal biopsies collected during a standard care endoscopy for patient with esophageal atresia during the first year of life
Intervention Type
Procedure
Intervention Name(s)
Esophageal biopsy collection during anastomosis
Intervention Description
During the anastomosis, the surgeon will collect an esophageal mucosa biopsy
Primary Outcome Measure Information:
Title
Comparison of the mRNA expression from esophageal biopsies between long and short term storage
Description
Transcriptomic profiles will be generated by the identification of mRNA and miRNA expression by 3'RNA-seq and sRNA-seq technologies. Differential expression between long and short term storage will be performed.[exploratory and untargeted analysis]
Time Frame
The biopsies will be collected during the first year of life
Title
Comparison of the metabolites identification from esophageal biopsies between long and short term storage
Description
Metabolomic profiles will be generated (untargeted analysis that will include mnulmerous lipids, amino-acids, ...). Differential expression between long and short term storage will be performed. [exploratory and untargeted analysis]
Time Frame
The biopsies will be collected during the first year of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anastomosis group :
Born with esophageal atresia Anastomosis performed in Lille hospital Parents consent
- Control group : Born with esophageal atresia
Exclusion Criteria:
Both groups :
Parents refusing to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie Leroy, PhD
Phone
+33625372349
Email
melanie.leroy@chu-lille.fr
Facility Information:
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59007
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mélanie Leroy, PhD
Phone
+33625372349
Email
melanie.leroy@chu-lille.fr
First Name & Middle Initial & Last Name & Degree
Rony Sfeir, MD
First Name & Middle Initial & Last Name & Degree
Gottrand Frédéric, MD
First Name & Middle Initial & Last Name & Degree
Aumar Madeleine, MD
First Name & Middle Initial & Last Name & Degree
Tran Léa, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Molecular Signatures of Esophageal Atresia
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