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Trial record 1 of 3 for:    "Cystic adenomatoid malformation of lung"
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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
Information provided by (Responsible Party):

Study Description
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
Congenital Cystic Adenomatoid Malformation (CCAM) Genetic: Patient

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
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
Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

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
Contacts and Locations

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

Necker-Enfants Malades Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Christophe Delacourt, MD, PhD Necker-Enfants Malades Hospital
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01732185     History of Changes
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:
Congenital Abnormalities
Cystic Adenomatoid Malformation of Lung, Congenital
Lung Diseases
Respiratory Tract Diseases
Respiratory System Abnormalities