Congenital Lung Anomalies (CLA) Swiss Database (CLADatabase)
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ClinicalTrials.gov Identifier: NCT03044769 |
Recruitment Status :
Recruiting
First Posted : February 7, 2017
Last Update Posted : April 16, 2020
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Condition or disease | Intervention/treatment |
---|---|
Congenital Lung Malformation Congenital Lung Cyst Sequestrum Bronchogenic Cancer Pleuropulmonary Blastoma Acinar Dysplasia | Procedure: Malformations resection |
- 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 Type : | Observational [Patient Registry] |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 10 Years |
Official Title: | Follow up of Congenital Lung Anomalies (CLA) With Antenatal Diagnosis - a Swiss Multicentric Database |
Actual Study Start Date : | April 1, 2016 |
Estimated Primary Completion Date : | June 1, 2022 |
Estimated Study Completion Date : | April 1, 2026 |

Group/Cohort | Intervention/treatment |
---|---|
Patient with CLA with surgery |
Procedure: Malformations resection
Resection of the malformation lung sections with a healthy adjacent part |
Patient with CLA without surgery |
- 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
- Report biomarkers implicated in CLA with a potential role in lesion oncogenic transformation [ Time Frame: 1 year post surgery ]Comparison using exome analysis : CLA lesion, healthy adjacent part and blood DNA
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- All patients diagnosed with congenital lung anomalies
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044769
Contact: Isabelle Ruchonnet-Métrailler, MD PhD | isabelle.ruchonnet-metrailler@hcuge.ch | ||
Contact: Isabelle Andrieu Vidal, MD PhD | isabelle.andrieuvidal@hcuge.ch |
Switzerland | |
Geneva University Hospital | Recruiting |
Geneva, Switzerland, 1205 | |
Contact: Mohamed-Rida Benissa, M.D., M.Sc., M.P.H. +33.62.866.40.47 mrbenissa@gmail.com | |
Contact: Isabelle Ruchonnet-Métrailler, MD PhD Isabelle.ruchonnet-metrailler@hcuge.ch | |
Sub-Investigator: Alain Gervaix, M.D | |
Sub-Investigator: Constance Barazzone Argiroffo, M.D |
Principal Investigator: | Isabelle Andrieu Vidal, MD PhD | University Hospital, Geneva | |
Principal Investigator: | Isabelle Ruchonnet-Métrailler, MD PhD | University Hospital, Geneva |
Responsible Party: | Isabelle Ruchonnet-Métrailler, Principal Investigator, University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT03044769 |
Other Study ID Numbers: |
CLA-2016 |
First Posted: | February 7, 2017 Key Record Dates |
Last Update Posted: | April 16, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Congenital Lung Anomalies |
Pulmonary Blastoma Congenital Abnormalities Neoplasms, Complex and Mixed Neoplasms by Histologic Type Neoplasms |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |