ClinicalTrials.gov
ClinicalTrials.gov Menu

Congenital Lung Anomalies (CLA) Swiss Database (CLADatabase)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03044769
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Isabelle Ruchonnet-Métrailler, University Hospital, Geneva

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Congenital Lung Malformation Congenital Lung Cyst Sequestrum Bronchogenic Cancer Pleuropulmonary Blastoma Acinar Dysplasia Procedure: Malformations resection

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Study Start Date : April 1, 2016
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : April 1, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 (%)

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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)

  7. 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


Secondary Outcome Measures :
  1. 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
To create a biobank with the different samples of patients undergoing surgery, healthy edge of resections being considered as control tissue. Leukocyte DNA will be compared with lung tissue DNA.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • All patients diagnosed with congenital lung anomalies

Exclusion Criteria:

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Contact: Isabelle Ruchonnet-Métrailler, MD PhD isabelle.ruchonnet-metrailler@hcuge.ch
Contact: Isabelle Andrieu Vidal, MD PhD isabelle.andrieuvidal@hcuge.ch

Locations
Switzerland
Geneva University Hospital Recruiting
Geneva, Switzerland, 1205
Contact: Isabelle Ruchonnet-Métrailler, MD PhD       Isabelle.ruchonnet-metrailler@hcuge.ch   
Principal Investigator: Isabelle Andrieu Vidal, MD PhD         
Principal Investigator: Isabelle Ruchonnet-Métrailler, MD PhD         
Sub-Investigator: Barbara Wildhaber, MD         
Sub-Investigator: Constance Barazzone Argiroffo, MD         
Sub-Investigator: Jean Marie Pellegrinelli, MD         
Sub-Investigator: Mehrak Anooshiravani- Dumont, MD         
Sub-Investigator: Anne-Laure Rougemont, MD         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Isabelle Andrieu Vidal, MD PhD University Hospital, Geneva
Principal Investigator: Isabelle Ruchonnet-Métrailler, MD PhD University Hospital, Geneva
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Responsible Party: Isabelle Ruchonnet-Métrailler, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03044769     History of Changes
Other Study ID Numbers: CLA-2016
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
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

Keywords provided by Isabelle Ruchonnet-Métrailler, University Hospital, Geneva:
Congenital Lung Anomalies

Additional relevant MeSH terms:
Congenital Abnormalities
Pulmonary Blastoma
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
 Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site