Congenital Lung Anomalies (CLA) Swiss Database

NCT ID: NCT03044769

Last Updated: 2020-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-01

Study Completion Date

2026-04-01

Brief Summary

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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

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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.

Conditions

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Congenital Lung Malformation Congenital Lung Cyst Sequestrum Bronchogenic Cancer Pleuropulmonary Blastoma Acinar Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with CLA with surgery

Malformations resection

Intervention Type PROCEDURE

Resection of the malformation lung sections with a healthy adjacent part

Patient with CLA without surgery

No interventions assigned to this group

Interventions

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Malformations resection

Resection of the malformation lung sections with a healthy adjacent part

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients diagnosed with congenital lung anomalies

Exclusion Criteria

* None
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Isabelle Ruchonnet-Métrailler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabelle Andrieu Vidal, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Isabelle Ruchonnet-Métrailler, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Geneva University Hospital

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Isabelle Ruchonnet-Métrailler, MD PhD

Role: CONTACT

Isabelle Andrieu Vidal, MD PhD

Role: CONTACT

Facility Contacts

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Mohamed-Rida Benissa, M.D., M.Sc., M.P.H.

Role: primary

+33.62.866.40.47

Isabelle Ruchonnet-Métrailler, MD PhD

Role: backup

Other Identifiers

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CLA-2016

Identifier Type: -

Identifier Source: org_study_id

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