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Trial record 1 of 1 for:    NCT01732185
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Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations (MAKP)

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ClinicalTrials.gov Identifier: NCT01732185
Recruitment Status : Unknown
Verified December 2015 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : November 22, 2012
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The aim of this study is to identify genetic abnormalities and molecular pathways associated with the occurrence of CCAM.

Condition or disease Intervention/treatment Phase
Congenital Cystic Adenomatoid Malformation (CCAM) Genetic: Patient Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations
Study Start Date : October 2012
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patient
congenital cystic adenomatoid malformations
Genetic: Patient
Blood and histological samples will be done at day of the inclusion.




Primary Outcome Measures :
  1. mRNA expression [ Time Frame: at Day 0 ]
    Transcriptomic analysis


Secondary Outcome Measures :
  1. Protein expression [ Time Frame: at Day 0 ]
    Proteomic expression

  2. Somatic genetic abnormalities [ Time Frame: at Day 0 ]
    CGH array



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children < 8 years
  • Thoracic surgery for congenital lung malformation
  • Parental written consent

Exclusion Criteria:

  • Children > 8 years
  • Previous infection of the malformation
  • Parental rebutal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732185


Locations
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France
Necker-Enfants Malades Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Christophe Delacourt, MD, PhD Necker-Enfants Malades Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01732185    
Other Study ID Numbers: P100510
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Congenital lung malformation
Congenital Cystic Adenomatoid Malformation
Cystic lung disease
Additional relevant MeSH terms:
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Cystic Adenomatoid Malformation of Lung, Congenital
Congenital Abnormalities
Lung Diseases
Respiratory Tract Diseases
Respiratory System Abnormalities