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Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations (MAKP)

Primary Purpose

Congenital Cystic Adenomatoid Malformation (CCAM)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Congenital Cystic Adenomatoid Malformation (CCAM) focused on measuring Congenital lung malformation, Congenital Cystic Adenomatoid Malformation, Cystic lung disease

Eligibility Criteria

undefined - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Necker-Enfants Malades Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient

Arm Description

congenital cystic adenomatoid malformations

Outcomes

Primary Outcome Measures

mRNA expression
Transcriptomic analysis

Secondary Outcome Measures

Protein expression
Proteomic expression
Somatic genetic abnormalities
CGH array

Full Information

First Posted
November 19, 2012
Last Updated
April 30, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01732185
Brief Title
Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations
Acronym
MAKP
Official Title
Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 11, 2012 (Actual)
Primary Completion Date
October 11, 2015 (Actual)
Study Completion Date
October 11, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cystic Adenomatoid Malformation (CCAM)
Keywords
Congenital lung malformation, Congenital Cystic Adenomatoid Malformation, Cystic lung disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Other
Arm Description
congenital cystic adenomatoid malformations
Intervention Type
Genetic
Intervention Name(s)
Patient
Intervention Description
Blood and histological samples will be done at day of the inclusion.
Primary Outcome Measure Information:
Title
mRNA expression
Description
Transcriptomic analysis
Time Frame
at Day 0
Secondary Outcome Measure Information:
Title
Protein expression
Description
Proteomic expression
Time Frame
at Day 0
Title
Somatic genetic abnormalities
Description
CGH array
Time Frame
at Day 0

10. Eligibility

Sex
All
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Delacourt, MD, PhD
Organizational Affiliation
Necker-Enfants Malades Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necker-Enfants Malades Hospital
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22726873
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.
Results Reference
background
PubMed Identifier
32019538
Citation
Lezmi G, Vibhushan S, Bevilaqua C, Crapart N, Cagnard N, Khen-Dunlop N, Boyle-Freyssaut C, Hadchouel A, Delacourt C. Congenital cystic adenomatoid malformations of the lung: an epithelial transcriptomic approach. Respir Res. 2020 Feb 4;21(1):43. doi: 10.1186/s12931-020-1306-5.
Results Reference
derived

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Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations

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