<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/NCT01732185</url>
  </required_header>
  <id_info>
    <org_study_id>P100510</org_study_id>
    <secondary_id>2012-A00538-35</secondary_id>
    <nct_id>NCT01732185</nct_id>
  </id_info>
  <brief_title>Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations</brief_title>
  <acronym>MAKP</acronym>
  <official_title>Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to identify genetic abnormalities and molecular pathways associated&#xD;
      with the occurrence of CCAM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Congenital lung malformations are rare diseases, characterized by the coexistence in the same&#xD;
      individual of normal lung and localized lung malformation. Among these malformations,&#xD;
      congenital cystic adenomatoid malformations (CCAM) represent the most important group, with&#xD;
      an estimated incidence between 1/11 000 and 1/35 000 births. The precise mechanisms leading&#xD;
      to these lung malformations remain poorly understood. This project aims to identify key&#xD;
      genetic and/or molecular mechanisms associated with the occurrence of CCAM. CCAMs are&#xD;
      collected during postnatal surgical resection. Parental agreement is required. A standardised&#xD;
      histologic description of malformations is performed for each sample. Normal lung tissue at&#xD;
      the periphery of the malformation is considered as control. Malformations will be analyzed in&#xD;
      a systematic way by proteome and transcriptome, after laser microdissection. Somatic genetic&#xD;
      abnormalities will also systematically be sought.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2012</start_date>
  <completion_date type="Actual">October 11, 2015</completion_date>
  <primary_completion_date type="Actual">October 11, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mRNA expression</measure>
    <time_frame>at Day 0</time_frame>
    <description>Transcriptomic analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Protein expression</measure>
    <time_frame>at Day 0</time_frame>
    <description>Proteomic expression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatic genetic abnormalities</measure>
    <time_frame>at Day 0</time_frame>
    <description>CGH array</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Congenital Cystic Adenomatoid Malformation (CCAM)</condition>
  <arm_group>
    <arm_group_label>Patient</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>congenital cystic adenomatoid malformations</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Patient</intervention_name>
    <description>Blood and histological samples will be done at day of the inclusion.</description>
    <arm_group_label>Patient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children &lt; 8 years&#xD;
&#xD;
          -  Thoracic surgery for congenital lung malformation&#xD;
&#xD;
          -  Parental written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children &gt; 8 years&#xD;
&#xD;
          -  Previous infection of the malformation&#xD;
&#xD;
          -  Parental rebutal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christophe Delacourt, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Necker-Enfants Malades Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Necker-Enfants Malades Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Kotecha S, Barbato A, Bush A, Claus F, Davenport M, Delacourt C, Deprest J, Eber E, Frenckner B, Greenough A, Nicholson AG, Anton-Pacheco JL, Midulla F. Antenatal and postnatal management of congenital cystic adenomatoid malformation. Paediatr Respir Rev. 2012 Sep;13(3):162-70; quiz 170-1. doi: 10.1016/j.prrv.2012.01.002. Epub 2012 Apr 25.</citation>
    <PMID>22726873</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Congenital lung malformation</keyword>
  <keyword>Congenital Cystic Adenomatoid Malformation</keyword>
  <keyword>Cystic lung disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Adenomatoid Malformation of Lung, Congenital</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01732185
org study id: P100510
secondary id: 2012-A00538-35
nct id: NCT01732185
lead sponsor: 
has dmc: No
The aim of this study is to identify genetic abnormalities and molecular pathways associated
      with the occurrence of CCAM.
Congenital lung malformations are rare diseases, characterized by the coexistence in the same
      individual of normal lung and localized lung malformation. Among these malformations,
      congenital cystic adenomatoid malformations (CCAM) represent the most important group, with
      an estimated incidence between 1/11 000 and 1/35 000 births. The precise mechanisms leading
      to these lung malformations remain poorly understood. This project aims to identify key
      genetic and/or molecular mechanisms associated with the occurrence of CCAM. CCAMs are
      collected during postnatal surgical resection. Parental agreement is required. A standardised
      histologic description of malformations is performed for each sample. Normal lung tissue at
      the periphery of the malformation is considered as control. Malformations will be analyzed in
      a systematic way by proteome and transcriptome, after laser microdissection. Somatic genetic
      abnormalities will also systematically be sought.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: mRNA expression
time frame: at Day 0
description: Transcriptomic analysis
measure: Protein expression
time frame: at Day 0
description: Proteomic expression
measure: Somatic genetic abnormalities
time frame: at Day 0
description: CGH array
arm group label: Patient
arm group type: Other
description: congenital cystic adenomatoid malformations
intervention type: Genetic
intervention name: Patient
description: Blood and histological samples will be done at day of the inclusion.
arm group label: Patient
criteria: 
gender: All
minimum age: N/A
maximum age: 8 Years
healthy volunteers: No
last name: Christophe Delacourt, MD, PhD
role: Principal Investigator
affiliation: Necker-Enfants Malades Hospital
facility: 
country: France
citation: Kotecha S, Barbato A, Bush A, Claus F, Davenport M, Delacourt C, Deprest J, Eber E, Frenckner B, Greenough A, Nicholson AG, Anton-Pacheco JL, Midulla F. Antenatal and postnatal management of congenital cystic adenomatoid malformation. Paediatr Respir Rev. 2012 Sep;13(3):162-70; quiz 170-1. doi: 10.1016/j.prrv.2012.01.002. Epub 2012 Apr 25.
PMID: 22726873
responsible party type: Sponsor
mesh term: Cystic Adenomatoid Malformation of Lung, Congenital
mesh term: Congenital Abnormalities