Congenital Lung Anomalies (CLA) Swiss Database

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03044769

Studienbeginn:
April 2016

Letztes Update:
16.04.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Pulmonary Blastoma

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
-

Sponsor:
University Hospital, Geneva

Collaborator:
-

Studienleiter

Isabelle Andrieu Vidal, MD PhD
Principal Investigator
University Hospital, Geneva

Isabelle Ruchonnet-Métrailler, MD PhD
Principal Investigator
University Hospital, Geneva

Kontakt

Isabelle Ruchonnet-Métrailler, MD PhD
Kontakt:
E-Mail: isabelle.ruchonnet-metrailler@hcuge.ch» Kontaktdaten anzeigen

Isabelle Andrieu Vidal, MD PhD
Kontakt:
E-Mail: isabelle.andrieuvidal@hcuge.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Geneva University Hospital
1205 Geneva
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Mohamed-Rida Benissa, M.D., M.Sc., M.P.H.
Phone: +33.62.866.40.47
E-Mail: mrbenissa@gmail.com

Isabelle Ruchonnet-Métrailler, MD PhD
E-Mail: Isabelle.ruchonnet-metrailler@hcuge.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- All patients diagnosed with congenital lung anomalies

Exclusion Criteria:

- None

Studien-Rationale

Primary outcome:

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:

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

Studien-Arme

Patient with CLA with surgery
Patient with CLA without surgery

Geprüfte Regime

Malformations resection:
Resection of the malformation lung sections with a healthy adjacent part

Quelle: ClinicalTrials.gov

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