Clinical Trial: European Management Platform for Childhood Interstitial Lung Diseases - chILD-EU Register and Biobank
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: Orphans Unite: chILD Better Together - European Management Platform for Childhood Interstitial Lung Diseases / chILD-EU - International Register and Biobank for Children´s Interstital Lung Diseas
Brief Summary: 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 Summary:
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 test
Sponsor: Matthias Griese
Current Primary Outcome: Included subjects with specific diagnosis [ Time Frame: 10 years ]
Original Primary Outcome:
- Included subjects with specific diagnosis [ Time Frame: 10 years ]
- Survival [ Time Frame: 10 years ]
Current Secondary Outcome: Survial [ Time Frame: 10 years ]
Original Secondary Outcome:
Information By: Ludwig-Maximilians - University of Munich
Dates:
Date Received: July 29, 2016
Date Started: January 2014
Date Completion:
Last Updated: August 1, 2016
Last Verified: August 2016
