Lung Diseases, InterstitialchILD-EUNCT02852928
European Management Platform for Childhood Interstitial Lung Diseases - chILD-EU Register and Biobank
An observational study of Lung Diseases, Interstitial and Pulmonary Alveolar Proteinosis, run by Matthias Griese at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Diseases, Interstitial, Pulmonary Alveolar Proteinosis, Pulmonary Eosinophilia
- How many people
- 1,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Dec 2013to Dec 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 400 prevalent patients with childhood interstitial lung disease (chILD) in Europe 100 incident chILD cases per year
Who may be able to join
- all children with suspected or
- verified diagnosis of ILD or
- masquerading as ILD and
- those with rare localized parenchymal lung diseases
Who cannot join
- other indication as inclusion criteria
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Germany1 site, 1 recruiting
- Recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Nicolaus Schwerk, MD, +49 (0) 511 5329 ext. 138, schwerk.nicolaus@mh-hannover.de
Martin Wetzke, MD, +49 (0) 511 5329 ext. 138
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University, Medical Faculty
Ankara, Sihhiye, 06100
Nural Kiper, Prof, +903123051224, nkiper@hacettepe.edu.tr
Nagehan Emiralioglu, Dr., +903123051334, nagehan.emiralioglu@hacettepe.edu.tr
United Kingdom1 site, 1 recruiting
- Recruiting
University of Edinburgh
Edinburgh, EH4 2XU
Steve Cuningham, Dr., +441315360640, steve.cunningham@nhs.net
Morag MaClean, +44131 537 3846 / 3878, chILD-UK@ed.ac.uk
About this study
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 Disease
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
Read the detailed description
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
- Lung Diseases, Interstitial, Pulmonary Alveolar Proteinosis, Pulmonary Eosinophilia, Pulmonary Fibrosis, Respiratory Distress Syndrome, Newborn, Child
- Keywords
- ILD; chILD
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Alveolar Proteinosis, Pulmonary Eosinophilia, Pulmonary Fibrosis, Respiratory Distress Syndrome, Newborn
What is being measured
The primary outcome is the main question the study is designed to answer.
Included subjects with specific diagnosis
Number of recruited subjects
Measured: 10 years
Secondary outcomes (1)
Survial
Survival of the participants
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startDec 2013
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Matthias Griese
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthias Griese, Ludwig-Maximilians - University of Munich
- Investigators
- Matthias Griese, Prof., Study chair, Klinikum der Universität München, Dr. von Haunersches Kinderspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852928
- Sponsor's protocol ID
- chILD-EU
- Acronym
- chILD-EU
- Status last verified
- Sep 2022
- First submitted
- 29 Jul 2016
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29056600Griese M, Reu-Hofer S, Ley-Zaporozhan J, Kammer B, Kruger-Stollfuss I, Micic S, Carlens J, Maier P, Rodler J, Mauss-Schwarzer K, Tran NB, Rapp CK, Gothe F, Marczak H, Lange J, Krenke K, Ring AM, Buchvald F, Stehling F, Jerkic PS, Trischler J, Proesmans M, Sismanlar T, Aslan A, Emiralioglu N, Kiper N, Hammerling S, Kilinc A, Prenzel F, Wiemers A, Moreno-Galdo A, Mayell S, Bhatt JM, Naehrlich L, Pahlke F, Wetzke M, Moeller A, Kappler M; chILD-EU collaborators; Schwerk N, Seidl E. Prevalence and disease trajectories of pulmonary fibrosis of childhood interstitial lung disease: a register-based, multicentre observational study. Lancet Respir Med. 2026 Jun 24:S2213-2600(26)00052-4. doi: 10.1016/S2213-2600(26)00052-4. Online ahead of print.
PubMed 42341791
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Disease
- ClinicalTrials.gov ID
- NCT02852928
- Acronym / sponsor ID
- chILD-EU / chILD-EU
- Conditions
- Lung Diseases, Interstitial, Pulmonary Alveolar Proteinosis, Pulmonary Eosinophilia, Pulmonary Fibrosis, Respiratory Distress Syndrome, Newborn, Child
- Keywords
- ILD; chILD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Matthias GrieseUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 400 prevalent patients with childhood interstitial lung disease (chILD) in Europe 100 incident chILD cases per year
Key inclusion criteria (4 listed)
- all children with suspected or
- verified diagnosis of ILD or
- masquerading as ILD and
- those with rare localized parenchymal lung diseases
Key exclusion criteria (1 listed)
- other indication as inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Included subjects with specific diagnosis
Time frame: 10 years
Number of recruited subjects
1 secondary outcome
Survial
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Background: PubMed 29056600Griese 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.
- Derived from this study: PubMed 42341791Griese M, Reu-Hofer S, Ley-Zaporozhan J, Kammer B, Kruger-Stollfuss I, Micic S, Carlens J, Maier P, Rodler J, Mauss-Schwarzer K, Tran NB, Rapp CK, Gothe F, Marczak H, Lange J, Krenke K, Ring AM, Buchvald F, Stehling F, Jerkic PS, Trischler J, Proesmans M, Sismanlar T, Aslan A, Emiralioglu N, Kiper N, Hammerling S, Kilinc A, Prenzel F, Wiemers A, Moreno-Galdo A, Mayell S, Bhatt JM, Naehrlich L, Pahlke F, Wetzke M, Moeller A, Kappler M; chILD-EU collaborators; Schwerk N, Seidl E. Prevalence and disease trajectories of pulmonary fibrosis of childhood interstitial lung disease: a register-based, multicentre observational study. Lancet Respir Med. 2026 Jun 24:S2213-2600(26)00052-4. doi: 10.1016/S2213-2600(26)00052-4. Online ahead of print.
- chILD-EU project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Griese, Prof. study chair
Klinikum der Universität München, Dr. von Haunersches Kinderspital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, Interstitial and Pulmonary Alveolar Proteinosis, run by Matthias Griese at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Turkey (Türkiye), United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias Griese, Prof. (+49/89/440057871, Matthias.Griese@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Included subjects with specific diagnosis (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02852928, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.