European Management Platform for Childhood Interstitial Lung Diseases - chILD-EU Register and Biobank

NCT ID: NCT02852928

Last Updated: 2022-09-21

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2029-12-31

Brief Summary

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Generation of a common European database and biobank Continous assessment and implementation of guidelines and treatment protocols Establishment of a large observational cohort of chILD patients Determination the value of outcomes used in child Assess treatment variations used, deliver data from defined protocols and linked outcomes

Detailed Description

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Objective 1: Generation of a common European database and biobank. The existing national programmes to collect data on chILD in three countries (France, Germany, UK) will enable the consortium to swiftly adapt current frameworks to a functionally appropriate pan-European web-based database and biobank. Importantly, compatibility with ongoing United States chILD data base developments will be factored in.

Objective 2: Continuous assessment and implementation of guidelines and treatment protocols. Our Standards Working Group will convene regularly. Initial tasks will establish (a) specific diagnostic pathways, including detailed protocols for gathering clinical information, blood testing, imaging and pathology ("Best Practice Checklist"); (b) international panels of clinicians, geneticists, radiologists and pathologists who will review every diagnosis to quality control the data; and (c) detailed protocols for follow up to generate natural history data.

Objective 3: Recruitment of a carefully characterized cohort of chILD patients. European wide recruitment and interdisciplinary critical peer review of all diagnoses submitted from across Europe is imperative. Each case will be given a diagnosis independently; if no firm diagnosis is possible, we will review the case periodically as new information becomes available. During the first year of the study, clinicians´ decisions according to local practice and outcomes will be independently monitored and assessed.

Objective 4: Determine the value of outcomes used in chILD. We will systematically optimize and clarify the relative weight of a large spectrum of single and composite clinical outcomes (using both clinician and carer scoring), sequential limited chest CT (to minimise radiation exposure), lung function testing, histopathological categorization of lung biopsies, serum markers and genetic tests. Variability, reproducibility and the effects of training on reading images will be investigated.

Objective 5: Assess treatment variations used, deliver data from defined protocols and linked outcomes. This project will analyse in detail treatment and outcomes within and between subjects using data collected. Analysis of the collected data will enable us to support the definition of trial protocols planned in the future.

Conditions

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Lung Diseases, Interstitial Pulmonary Alveolar Proteinosis Pulmonary Eosinophilia Pulmonary Fibrosis Respiratory Distress Syndrome, Newborn Child

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* all children with suspected or
* verified diagnosis of ILD or
* masquerading as ILD and
* those with rare localized parenchymal lung diseases
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Matthias Griese

OTHER

Sponsor Role lead

Responsible Party

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Matthias Griese

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Matthias Griese, Prof.

Role: STUDY_CHAIR

Klinikum der Universität München, Dr. von Haunersches Kinderspital

Locations

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Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Hacettepe University, Medical Faculty

Ankara, Sihhiye, Turkey (Türkiye)

Site Status RECRUITING

University of Edinburgh

Edinburgh, , United Kingdom

Site Status RECRUITING

Countries

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Germany Turkey (Türkiye) United Kingdom

Central Contacts

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Matthias Griese, Prof.

Role: CONTACT

+49/89/440057871

Katarzyna Michel, Dr. med.

Role: CONTACT

+49/89/440057878

Facility Contacts

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Nicolaus Schwerk, MD

Role: primary

+49 (0) 511 5329 ext. 138

Martin Wetzke, MD

Role: backup

+49 (0) 511 5329 ext. 138

Nural Kiper, Prof

Role: primary

+903123051224

Nagehan Emiralioglu, Dr.

Role: backup

+903123051334

Steve Cuningham, Dr.

Role: primary

+441315360640

Morag MaClean

Role: backup

+44131 537 3846 / 3878

References

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Griese M, Seidl E, Hengst M, Reu S, Rock H, Anthony G, Kiper N, Emiralioglu N, Snijders D, Goldbeck L, Leidl R, Ley-Zaporozhan J, Kruger-Stollfuss I, Kammer B, Wesselak T, Eismann C, Schams A, Neuner D, MacLean M, Nicholson AG, Lauren M, Clement A, Epaud R, de Blic J, Ashworth M, Aurora P, Calder A, Wetzke M, Kappler M, Cunningham S, Schwerk N, Bush A; the other chILD-EU collaborators. International management platform for children's interstitial lung disease (chILD-EU). Thorax. 2018 Mar;73(3):231-239. doi: 10.1136/thoraxjnl-2017-210519. Epub 2017 Oct 22.

Reference Type BACKGROUND
PMID: 29056600 (View on PubMed)

Related Links

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http://childeu.net

chILD-EU project website

Other Identifiers

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chILD-EU

Identifier Type: -

Identifier Source: org_study_id

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