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Completed

NCT Number: NCT01732185

Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations

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

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Key information

Conditions

Congenital Cystic Adenomatoid Malformation (CCAM) Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Adenomatoid Malformation of Lung, Congenital Cystic Disease Of Lung Lung Diseases Respiratory System Abnormalities Respiratory Tract Diseases

Age range

Up to 8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necker-Enfants Malades Hospital

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient

Genetic

Blood and histological samples will be done at day of the inclusion.

Primary outcomes

  1. mRNA expression

    Time frame: at Day 0

    Transcriptomic analysis

Secondary outcomes

  1. Protein expression

    Time frame: at Day 0

    Proteomic expression

  2. Somatic genetic abnormalities

    Time frame: at Day 0

    CGH array

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: MAKP

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 22, 2012
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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