Congenital Cystic Adenomatoid Malformation (CCAM)MAKPNCT01732185
Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations
A study testing Patient in people with Congenital Cystic Adenomatoid Malformation (CCAM), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to identify genetic abnormalities and molecular pathways associated with the occurrence of CCAM. Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Congenital Cystic Adenomatoid Malformation (CCAM)
- What is being tested?
- Patient
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2012to 11 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children < 8 years
- Thoracic surgery for congenital lung malformation
- Parental written consent
Who cannot join
- Children > 8 years
- Previous infection of the malformation
- Parental rebutal
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to identify genetic abnormalities and molecular pathways associated with the occurrence of CCAM.
Read the 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.
- Being tested
- Patient
- Keywords
- Congenital lung malformation, Congenital Cystic Adenomatoid Malformation, Cystic lung disease
- Medical subject headings
- Cystic Adenomatoid Malformation of Lung, Congenital, Cystic Disease Of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatientGenetic
Blood and histological samples will be done at day of the inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Other | congenital cystic adenomatoid malformations Receives: Genetic: Patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA expression
Transcriptomic analysis
Measured: at Day 0
Secondary outcomes (2)
Protein expression
Proteomic expression
Measured: at Day 0
Somatic genetic abnormalities
CGH array
Measured: at Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study start11 Oct 2012
- Primary completion11 Oct 2015
- Study completion11 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Cystic Adenomatoid Malformation (CCAM)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christophe Delacourt, MD, PhD, Principal investigator, Necker-Enfants Malades Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732185
- Sponsor's protocol ID
- P100510
- Other IDs
- 2012-A00538-35
- Acronym
- MAKP
- Status last verified
- Sep 2025
- First submitted
- 19 Nov 2012
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22726873Lezmi 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.
PubMed 32019538
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations
- ClinicalTrials.gov ID
- NCT01732185
- Acronym / sponsor ID
- MAKP / P100510
- Keywords
- Congenital lung malformation, Congenital Cystic Adenomatoid Malformation, Cystic lung disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 11 Oct 2012 (actual)
- Primary completion
- 11 Oct 2015 (actual)
- Study completion
- 11 Oct 2015 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Other | Genetic: Patientcongenital cystic adenomatoid malformations |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children < 8 years
- Thoracic surgery for congenital lung malformation
- Parental written consent
Key exclusion criteria (3 listed)
- Children > 8 years
- Previous infection of the malformation
- Parental rebutal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatientBlood and histological samples will be done at day of the inclusion. | Genetic | Patient |
Primary outcome
mRNA expression
Time frame: at Day 0
Transcriptomic analysis
2 secondary outcomes
Protein expression
Time frame: at Day 0
Somatic genetic abnormalities
Time frame: at Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 22726873Kotecha 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 publication: PubMed 32019538Lezmi 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Delacourt, MD, PhD principal investigator
Necker-Enfants Malades Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient in people with Congenital Cystic Adenomatoid Malformation (CCAM), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA expression (time frame: at Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01732185, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.