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Clinical Trials/NCT01732185
NCT01732185
Completed
N/A

Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations

Assistance Publique - Hôpitaux de Paris1 site in 1 country45 target enrollmentOctober 11, 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Congenital Cystic Adenomatoid Malformation (CCAM)
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
45
Locations
1
Primary Endpoint
mRNA expression
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 11, 2012
End Date
October 11, 2015
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

mRNA expression

Time Frame: at Day 0

Transcriptomic analysis

Secondary Outcomes

  • Protein expression(at Day 0)
  • Somatic genetic abnormalities(at Day 0)

Study Sites (1)

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