xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05995171</url>
    </required_header>
    <id_info>
      <org_study_id>2022_0483</org_study_id>
      <nct_id>NCT05995171</nct_id>
    </id_info>
    <brief_title>Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence</brief_title>
    <acronym>TransEAsome</acronym>
    <official_title>Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Lille</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Lille</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Oesophageal atresia (OAEA), a malformation of the oesophagus present from birth, is&#xD;
        characterized by the interruption of the continuity of the oesophagus, which then ends in a&#xD;
        cul-de-sac. (Source: Fimatho) An operation is then required to restore continuity to the&#xD;
        esophagus. Although this operation enables the vast majority of children to survive the&#xD;
        neonatal period, health problems such as gastro-oesophageal reflux, eating difficulties,&#xD;
        respiratory problems and growth problems persist throughout life.&#xD;
  &#xD;
        The aim of the project is to create a prospective cohort of adolescents aged 13/14, nested in&#xD;
        the national AO registry. of adolescents born with esophageal atresia, including a biobank of&#xD;
        esophageal mucosa and plasma blood samples. Once the clinical and omic data have been&#xD;
        collected, the data will be transferred to the France Cohortes information system for&#xD;
        analysis, in order to assess the long-term outcome of this rare disease and establish&#xD;
        multi-omic profiles. Once the clinical data have been collected and the omics data (derived&#xD;
        from analysis of the biobank's biological samples) have been generated, they will be analyzed&#xD;
        by the project partners to assess the long-term outcome of OA and establish multiomic&#xD;
        profiles. The raw data will be available on the France Cohorte platform.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 5, 2023</start_date>
    <completion_date type="Anticipated">December 5, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 5, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia</measure>
      <time_frame>13-14 years</time_frame>
      <description>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]</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the prevalence of GERD at 13-14 years of age</measure>
      <time_frame>Birth,1 year, 6 years and 13-14 years</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life, nutritional status and respiratory complications</measure>
      <time_frame>13-14 years</time_frame>
      <description>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.&#xD;
  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).&#xD;
  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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsie</measure>
      <time_frame>13-14 years</time_frame>
      <description>metabolites, proteins and methylation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsie</measure>
      <time_frame>13-14 years</time_frame>
      <description>metabolites, proteins and methylation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Omics and multi omics profiles in plasma</measure>
      <time_frame>13-14 years</time_frame>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Esophageal Atresia</condition>
    <arm_group>
      <arm_group_label>Esophageal atresia arm</arm_group_label>
      <description>Patient with esophageal atresia</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control arm</arm_group_label>
      <description>Patient without esophageal atresia</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire</intervention_name>
      <description>Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL</description>
      <arm_group_label>Esophageal atresia arm</arm_group_label>
      <arm_group_label>control arm</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          children aged 13 to 14 born with oesophageal atresia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For the oesophagal atresia group :&#xD;
  &#xD;
            -  Born with oesophageal atresia (AO) in France or in French overseas departments and&#xD;
               territories&#xD;
  &#xD;
            -  Operated at birth for an AO&#xD;
  &#xD;
            -  Aged 13 or 14 during the recruitment period&#xD;
  &#xD;
            -  Patient willing to comply with all study procedures and duration&#xD;
  &#xD;
          For the blood sub-study :&#xD;
  &#xD;
            -  Upper GI endoscopy performed as part of care between 13 and 14 years of age with&#xD;
               esophageal mucosal biopsy sampling&#xD;
  &#xD;
            -  Patient having given written consent to participate in the study&#xD;
  &#xD;
          For the control arm:&#xD;
  &#xD;
            -  Aged 13 or 14 during the recruitment period&#xD;
  &#xD;
            -  Upper GI endoscopy performed as part of care for chronic or acute digestive signs to&#xD;
               rule out organic etiology (peptic esophagitis, gastric esophagitis, eosinophilic&#xD;
               esophagitis or ulcer)&#xD;
  &#xD;
            -  Normal endoscopy and histology&#xD;
  &#xD;
            -  No chronic progressive disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  For the oesophagal atresia arm :&#xD;
  &#xD;
            -  Concurrent participation in an interventional trial and in the 3 months prior to&#xD;
               inclusion&#xD;
  &#xD;
            -  Parents refusing to participate in the study&#xD;
  &#xD;
          For the control arm :&#xD;
  &#xD;
            -  Histologically non-normal esophageal biopsy&#xD;
  &#xD;
            -  Parents refusing to participate in the study&#xD;
  &#xD;
            -  Child with known organic pathology&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>CHU de Lille Hôpital Jeanne de Flandre</name>
        <address>
          <city>Lille</city>
          <state>Nord</state>
          <zip>59000</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Frédéric Frédéric</last_name>
      </contact>
      <investigator>
        <last_name>Frédéric Frédéric</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Esophageal Atresia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05995171
  org study id: 2022_0483
  nct id: NCT05995171
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Case-Only
  time perspective: Prospective
  measure: prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia
  time frame: 13-14 years
  description: 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]
  measure: the prevalence of GERD at 13-14 years of age
  time frame: Birth,1 year, 6 years and 13-14 years
  description: 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).
  measure: Quality of life, nutritional status and respiratory complications
  time frame: 13-14 years
  description: 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).
  measure: Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsie
  time frame: 13-14 years
  description: metabolites, proteins and methylation
  measure: Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsie
  time frame: 13-14 years
  description: metabolites, proteins and methylation
  measure: Omics and multi omics profiles in plasma
  time frame: 13-14 years
  arm group label: Esophageal atresia arm
  description: Patient with esophageal atresia
  arm group label: control arm
  description: Patient without esophageal atresia
  intervention type: Other
  intervention name: Questionnaire
  description: Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL
  arm group label: Esophageal atresia arm
  arm group label: control arm
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 14 Years
  healthy volunteers: No
  facility: 
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Esophageal Atresia
  sharing ipd: No