Congenital Lung MalformationCLADatabaseNCT03044769
Congenital Lung Anomalies (CLA) Swiss Database
An observational study of Congenital Lung Malformation and Congenital Lung Cyst, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Congenital lung anomalies include different pathologies such as congenital cystic adenomatoid malformation, pulmonary sequestration, bronchial atresia, emphysema, bronchogenic cyst. They concern less than 1/10000 births and their physiopathological origin is still poorly understood. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Congenital Lung Malformation, Congenital Lung Cyst, Sequestrum
- What is being tested?
- Malformations resection
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2016to 1 Apr 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Recruitment for this study is performed through a discussion with parents of the child during prenatal and postnatal medical consultations. Blood samples will be collected during surgery.
Who may be able to join
- All patients diagnosed with congenital lung anomalies
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Isabelle Ruchonnet-Métrailler, MD PhD contact
Isabelle Andrieu Vidal, MD PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospital
Geneva, 1205
Mohamed-Rida Benissa, M.D., M.Sc., M.P.H., +33.62.866.40.47, mrbenissa@gmail.com
Isabelle Ruchonnet-Métrailler, MD PhD, Isabelle.ruchonnet-metrailler@hcuge.ch
About this study
Official title: Follow up of Congenital Lung Anomalies (CLA) With Antenatal Diagnosis - a Swiss Multicentric Database
Congenital lung anomalies include different pathologies such as congenital cystic adenomatoid malformation, pulmonary sequestration, bronchial atresia, emphysema, bronchogenic cyst. They concern less than 1/10000 births and their physiopathological origin is still poorly understood. The main goal of this project is to pool the cases from different swiss centers on a prospective cohort study, first to increase knowledge of clinical and radiological evolution and their correlation with histological data, and second to analyse the pathological embryological mechanism underlying these malformations.
Read the detailed description
- To register prospectively clinical, biological, radiological and histological datas in a multicentric database (secured internet link, via Secutrial® software). for children with prenatal diagnosis of this kind of malformation. This study is conducted by a multidisciplinary team, involving obstetricians, neonatologists, pneumologists, pediatric surgeons, radiologists and anatomopathologists.
- To create a tissue biobank
Outcomes:
- Contribute to the definition of a standardized procedure at the Swiss level for the treatment of patients suffering from these malformations,
- Improve the assessment of lesion evolution related to CLA, and
- Possibly validate some biomarkers, which could help to identify individuals at risk. On the long term, these results could also support the development of innovative therapies targeting the factors involved in lung development.
- Conditions
- Congenital Lung Malformation, Congenital Lung Cyst, Sequestrum, Bronchogenic Cancer, Pleuropulmonary Blastoma, Acinar Dysplasia
- Being tested
- Malformations resection
- Keywords
- Congenital Lung Anomalies
- Medical subject headings
- Cystic Adenomatoid Malformation of Lung, Congenital, Pleuropulmonary blastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malformations resectionProcedure or surgery
Resection of the malformation lung sections with a healthy adjacent part
| Study group | Role | What they receive |
|---|---|---|
| Patient with CLA with surgery | Not described Receives: Procedure: Malformations resection | |
| Patient with CLA without surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical of patients with CLA between different time point
Clinical measurements: size (cm), weight (kg), saturation (%)
Measured: Birth, 1 month of life, 4 months of life, 9-18 months of life, 6 months post surgery, 1 year post surgery, 7 years old, 10 years old, 12 years old
Analysis of CLA physiopathology
Analysis of growth factors, transcription factors and extracellular components implicated in CLA genesis by immunohistochemistry, transcriptomic and proteomic methods
Measured: samples collected during surgery
Change in lung function
FEV1 (l/min), FEV1/FVC (%)TLC (L) DLCO (ml/min/mmHg)
Measured: 7 years old,10 years old, 12 years old, 16 years old
Change in Scar aspect and thoracic deformation of patients with CLA between different time point
Description
Measured: 6 months post surgery, 1 year post surgery, 7 years old, 10 years old, 12 years old
Change in lung radiological images of patients with CLA between different time point
Chest X-ray and Thoracic CT Scan lesion description
Measured: 1 month of life, 4 months of life, 9-18 months of life, 6 months post surgery, 1 year post surgery, 7 years old, 10 years old, 12 years old
Change in lesion size described by antenatal ultrasound of patients with CLA between different time point
lesion size (mm) CVR, estimated wight (gr), Head circumferences (cm)
Measured: 22, 28, 32 and 37 weeks of gestation
Change in lesion description by antenatal ultrasound of patients with CLA between different time point
Lesion description (micro cysts, macrocysts),lesion localisation
Measured: 22, 28, 32 and 37 weeks of gestation
Secondary outcomes (1)
Report biomarkers implicated in CLA with a potential role in lesion oncogenic transformation
Comparison using exome analysis : CLA lesion, healthy adjacent part and blood DNA
Measured: 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Apr 2016
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Lung MalformationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Ruchonnet-Métrailler, University Hospital, Geneva
- Investigators
- Isabelle Andrieu Vidal, MD PhD, Principal investigator, University Hospital, GenevaIsabelle Ruchonnet-Métrailler, MD PhD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044769
- Sponsor's protocol ID
- CLA-2016
- Acronym
- CLADatabase
- Status last verified
- Apr 2020
- First submitted
- 31 Jan 2017
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Congenital Lung Anomalies (CLA) With Antenatal Diagnosis - a Swiss Multicentric Database
- ClinicalTrials.gov ID
- NCT03044769
- Acronym / sponsor ID
- CLADatabase / CLA-2016
- Conditions
- Congenital Lung Malformation, Congenital Lung Cyst, Sequestrum, Bronchogenic Cancer, Pleuropulmonary Blastoma, Acinar Dysplasia
- Keywords
- Congenital Lung Anomalies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 7 Feb 2017 (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.
Congenital lung anomalies include different pathologies such as congenital cystic adenomatoid malformation, pulmonary sequestration, bronchial atresia, emphysema, bronchogenic cyst. They concern less than 1/10000 births and their physiopathological origin is still poorly understood. The main goal of this project is to pool the cases from different swiss centers on a prospective cohort study, first to increase knowledge of clinical and radiological evolution and their correlation with histological data, and second to analyse the pathological embryological mechanism underlying these malformations.
Detailed description
- To register prospectively clinical, biological, radiological and histological datas in a multicentric database (secured internet link, via Secutrial® software). for children with prenatal diagnosis of this kind of malformation. This study is conducted by a multidisciplinary team, involving obstetricians, neonatologists, pneumologists, pediatric surgeons, radiologists and anatomopathologists.
- To create a tissue biobank
Outcomes:
- Contribute to the definition of a standardized procedure at the Swiss level for the treatment of patients suffering from these malformations,
- Improve the assessment of lesion evolution related to CLA, and
- Possibly validate some biomarkers, which could help to identify individuals at risk. On the long term, these results could also support the development of innovative therapies targeting the factors involved in lung development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with CLA with surgery | – | Procedure: Malformations resection |
| Patient with CLA without surgery | – | – |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Recruitment for this study is performed through a discussion with parents of the child during prenatal and postnatal medical consultations. Blood samples will be collected during surgery.
Key inclusion criteria (1 listed)
- All patients diagnosed with congenital lung anomalies
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Malformations resectionResection of the malformation lung sections with a healthy adjacent part | Procedure or surgery | Patient with CLA with surgery |
Primary outcome
Change in clinical of patients with CLA between different time point
Time frame: Birth, 1 month of life, 4 months of life, 9-18 months of life, 6 months post surgery, 1 year post surgery, 7 years old, 10 years old, 12 years old
Clinical measurements: size (cm), weight (kg), saturation (%)
Analysis of CLA physiopathology
Time frame: samples collected during surgery
Analysis of growth factors, transcription factors and extracellular components implicated in CLA genesis by immunohistochemistry, transcriptomic and proteomic methods
Change in lung function
Time frame: 7 years old,10 years old, 12 years old, 16 years old
FEV1 (l/min), FEV1/FVC (%)TLC (L) DLCO (ml/min/mmHg)
Change in Scar aspect and thoracic deformation of patients with CLA between different time point
Time frame: 6 months post surgery, 1 year post surgery, 7 years old, 10 years old, 12 years old
Description
Change in lung radiological images of patients with CLA between different time point
Time frame: 1 month of life, 4 months of life, 9-18 months of life, 6 months post surgery, 1 year post surgery, 7 years old, 10 years old, 12 years old
Chest X-ray and Thoracic CT Scan lesion description
Change in lesion size described by antenatal ultrasound of patients with CLA between different time point
Time frame: 22, 28, 32 and 37 weeks of gestation
lesion size (mm) CVR, estimated wight (gr), Head circumferences (cm)
Change in lesion description by antenatal ultrasound of patients with CLA between different time point
Time frame: 22, 28, 32 and 37 weeks of gestation
Lesion description (micro cysts, macrocysts),lesion localisation
1 secondary outcome
Report biomarkers implicated in CLA with a potential role in lesion oncogenic transformation
Time frame: 1 year post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Isabelle Ruchonnet-Métrailler, MD PhD contact
Isabelle Andrieu Vidal, MD PhD contact
Isabelle Andrieu Vidal, MD PhD principal investigator
University Hospital, Geneva
Isabelle Ruchonnet-Métrailler, MD PhD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Lung Malformation and Congenital Lung Cyst, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Apr 2020. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Ruchonnet-Métrailler, MD PhD (isabelle.ruchonnet-metrailler@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical of patients with CLA between different time point (time frame: Birth, 1 month of life, 4 months of life, 9-18 months of life, 6 months post surgery, 1 year post surgery, 7 years old, 10 years old, 12 years old). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2020.