This trial is active, not recruiting.

Condition congenital cystic adenomatoid malformation (ccam)
Treatment patient
Sponsor Assistance Publique - Hôpitaux de Paris
Start date October 2012
End date December 2015
Trial size 45 participants
Trial identifier NCT01732185, P100510


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
congenital cystic adenomatoid malformations
Blood and histological samples will be done at day of the inclusion.

Primary Outcomes

mRNA expression
time frame: at Day 0

Secondary Outcomes

Protein expression
time frame: at Day 0
Somatic genetic abnormalities
time frame: at Day 0

Eligibility Criteria

Male or female participants up to 8 years old.

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

Additional Information

Official title Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations
Principal investigator Christophe Delacourt, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.