NCT01732185

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2015

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

November 19, 2012

Last Update Submit

September 1, 2025

Conditions

Congenital Cystic Adenomatoid Malformation (CCAM)

Keywords

Congenital lung malformationCongenital Cystic Adenomatoid MalformationCystic lung disease

Outcome Measures

Primary Outcomes (1)

  • mRNA expression

    Transcriptomic analysis

    at Day 0

Secondary Outcomes (2)

  • Protein expression

    at Day 0

  • Somatic genetic abnormalities

    at Day 0

Study Arms (1)

Patient

OTHER

congenital cystic adenomatoid malformations

Genetic: Patient

Interventions

PatientGENETIC

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

Patient

Eligibility Criteria

AgeUp to 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children \< 8 years
  • Thoracic surgery for congenital lung malformation
  • Parental written consent

You may not qualify if:

  • Children \> 8 years
  • Previous infection of the malformation
  • Parental rebutal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker-Enfants Malades Hospital

Paris, 75015, France

Location

Related Publications (2)

  • 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.

    PMID: 32019538BACKGROUND

  • 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.

    PMID: 22726873BACKGROUND

MeSH Terms

Conditions

Cystic Adenomatoid Malformation of Lung, CongenitalCystic Disease Of Lung

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiratory System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Christophe Delacourt, MD, PhD

    Necker-Enfants Malades Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 22, 2012

Study Start

October 11, 2012

Primary Completion

October 11, 2015

Study Completion

October 11, 2015

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

FR(1)