- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07615504
Better Tests- Improving Diagnostic Accuracy and Prognostication in Interstitial Lung Diseases (Better Tests)
Patients with interstitial lung diseases (ILD) suffer significant delays in obtaining a diagnosis, and objective evidence of support for immunosuppressive therapies, due to weaknesses in the diagnostic tests available in ILD clinics.
This project will assess several non-invasive assessments, focusing on blood and breath based sampling, to identify candidate tests that may translate through to routine clinical use. The tests being assessed will be initially employed in Pigeon Fanciers, a group recognised to be at high risk of developing ILD compared to age matched controls, due to their regular exposure to a known cause of ILD. Candidate tests will also be assessed for change over time in this group. Tests which show promise will then be utilised in patients with ILD diagnoses, including those with severe respiratory failure, to assess their acceptability to patients and their ability to provide useful prognostic information, to allow powering of future definitive clinical trials.
Study Overview
Status
Conditions
Detailed Description
Pigeon Fanciers attending a recruitment event at one of the large national meetings for the sport will undergo assessments after completion of informed consent. The basic assessments include collection of height, weight and lung function (e.g. spirometry). In addition we will collect basic information about current health, past medical history and current pigeon keeping habits (number kept, time spent with birds etc). Participants will then have a blood sample taken for collection of antibody level against Pigeons, and for storage for subsequent processing of relevant candidate objective tests. Participants will also perform an additional breathing test to allow collection of exhaled air, which will be analysed on site or via subsequent testing (dependent on test required). Results will be linked to symptoms on exposure to their pigeons and any subsequent diagnoses obtained.
Subsequent follow up of the Pigeon Fancier cohort, again via the participants attendance at large national meetings, will allow repeat of the candidate tests, enabling determination of natural variation and the effect of change in exposure or development of new medical conditions. We will also examine the dynamic change in candidate tests following natural exposures to causes of ILD, by performing the tests with a subset of Pigeon Fanciers before, during and after exposure to their birds.
Patients attending Interstitial Lung Disease clinics in NHS Tayside, and when admitted with their Interstitial Lung Disease, will be offered the opportunity to perform the non-invasive assessments available to Pigeon Fanciers, with their results being linked to subsequent clinical outcomes (progression of disease, response to treatment and time to death).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mark Spears, PhD FRCP
- Phone Number: +44 1738 473861
- Email: mspears001@dundee.ac.uk
Study Locations
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Blackpool, United Kingdom, FY1 1HU
- Recruiting
- Winter Gardens
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Contact:
- Mark Spears, PhD FRCP
- Phone Number: 44 1253 629600
- Email: mspears001@dundee.ac.uk
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Principal Investigator:
- Mark Spears, PhD FRCP
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Dundee, United Kingdom, DD21UB
- Recruiting
- Ninewells Hospital
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Principal Investigator:
- Mark Spears, PhD FRCP
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Contact:
- Mark Spears, PhD FRCP
- Phone Number: 44 1382 660111
- Email: mspears001@dundee.ac.uk
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Perth, United Kingdom, PH1 1NX
- Recruiting
- Perth Royal Infirmary
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Principal Investigator:
- Mark Spears, PhD FRCP
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Contact:
- Mar Spears, PhD FRCP
- Phone Number: 44 1738 473861
- Email: mspears001@dundee.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
To participate subjects will either have to be active Pigeon Fanciers, or will be either attending ILD clinics for management of their interstitial lung disease or will present acutely to hospital services with severe respiratory failure due to ILD.
Exclusion Criteria:
Unable to provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Pigeon Fanciers
Active Pigeon Fanciers
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Clinic patients with ILD
Patients with established Interstitial Lung Disease attending clinic
|
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Hospital patients with ILD
Patients with established Interstitial Lung Disease admitted due to their condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prediction of subsequent clinical outcomes
Time Frame: 5 years
|
The utilised tests will be examined for their ability to accurately predict the subsequent diagnostic label for ILD and clinical behaviour
|
5 years
|
|
Acceptability to participants
Time Frame: 5 years
|
The tests employed will be assessed for their ease of performance and acceptability from a participant perspective
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark Spears, PhD FRCP, NHS Tayside and University of Dundee
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3-067-24
- Charity (Other Grant/Funding Number: British Pigeon Fanciers Medical Research Charity)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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