European Management Platform for Childhood Interstitial Lung Diseases - chILD-EU Register and Biobank
NCT ID: NCT02852928
Last Updated: 2022-09-21
Study Results
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Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2013-12-31
2029-12-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* verified diagnosis of ILD or
* masquerading as ILD and
* those with rare localized parenchymal lung diseases
ALL
No
Sponsors
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Matthias Griese
OTHER
Responsible Party
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Matthias Griese
Prof. Dr. med.
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
Hacettepe University, Medical Faculty
Ankara, Sihhiye, Turkey (Türkiye)
University of Edinburgh
Edinburgh, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Martin Wetzke, MD
Role: backup
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.
Related Links
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chILD-EU project website
Other Identifiers
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chILD-EU
Identifier Type: -
Identifier Source: org_study_id
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