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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Mark Spears, PhD FRCP
- Numero di telefono: +44 1738 473861
- Email: mspears001@dundee.ac.uk
Luoghi di studio
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Blackpool, Regno Unito, FY1 1HU
- Reclutamento
- Winter Gardens
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Contatto:
- Mark Spears, PhD FRCP
- Numero di telefono: 44 1253 629600
- Email: mspears001@dundee.ac.uk
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Investigatore principale:
- Mark Spears, PhD FRCP
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Dundee, Regno Unito, DD21UB
- Reclutamento
- Ninewells Hospital
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Investigatore principale:
- Mark Spears, PhD FRCP
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Contatto:
- Mark Spears, PhD FRCP
- Numero di telefono: 44 1382 660111
- Email: mspears001@dundee.ac.uk
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Perth, Regno Unito, PH1 1NX
- Reclutamento
- Perth Royal Infirmary
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Investigatore principale:
- Mark Spears, PhD FRCP
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Contatto:
- Mar Spears, PhD FRCP
- Numero di telefono: 44 1738 473861
- Email: mspears001@dundee.ac.uk
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Prediction of subsequent clinical outcomes
Lasso di tempo: 5 years
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The utilised tests will be examined for their ability to accurately predict the subsequent diagnostic label for ILD and clinical behaviour
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5 years
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Acceptability to participants
Lasso di tempo: 5 years
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The tests employed will be assessed for their ease of performance and acceptability from a participant perspective
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5 years
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mark Spears, PhD FRCP, NHS Tayside and University of Dundee
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 3-067-24
- Charity (Altro numero di sovvenzione/finanziamento: British Pigeon Fanciers Medical Research Charity)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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