Clinical trial NCT03044769: Congenital Lung Anomalies (CLA) Swiss Database
Official title: Follow up of Congenital Lung Anomalies (CLA) With Antenatal Diagnosis - a Swiss Multicentric Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Lung Malformation
Congenital Lung Cyst
Sequestrum
Bronchogenic Cancer
Pleuropulmonary Blastoma
Acinar Dysplasia
Keywords: Congenital Lung Anomalies
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 100
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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: 1. 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.
2. To create a tissue biobank

Outcomes:

1. Contribute to the definition of a standardized procedure at the Swiss level for the treatment of patients suffering from these malformations,
2. Improve the assessment of lesion evolution related to CLA, and
3. 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.

Eligibility criteria: Inclusion Criteria:

* All patients diagnosed with congenital lung anomalies

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in clinical of patients with CLA between different time point
timeFrame: 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
measure: Analysis of CLA physiopathology
timeFrame: samples collected during surgery
measure: Change in lung function
timeFrame: 7 years old,10 years old, 12 years old, 16 years old
measure: Change in Scar aspect and thoracic deformation of patients with CLA between different time point
timeFrame: 6 months post surgery, 1 year post surgery, 7 years old, 10 years old, 12 years old
measure: Change in lung radiological images of patients with CLA between different time point
timeFrame: 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
measure: Change in lesion size described by antenatal ultrasound of patients with CLA between different time point
timeFrame: 22, 28, 32 and 37 weeks of gestation
measure: Change in lesion description by antenatal ultrasound of patients with CLA between different time point
timeFrame: 22, 28, 32 and 37 weeks of gestation
Secondary outcomes:
measure: Report biomarkers implicated in CLA with a potential role in lesion oncogenic transformation
timeFrame: 1 year post surgery
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Isabelle Andrieu Vidal, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Isabelle Ruchonnet-Métrailler, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: