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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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).
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mark Spears, PhD FRCP
- Numéro de téléphone: +44 1738 473861
- E-mail: mspears001@dundee.ac.uk
Lieux d'étude
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Blackpool, Royaume-Uni, FY1 1HU
- Recrutement
- Winter Gardens
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Contact:
- Mark Spears, PhD FRCP
- Numéro de téléphone: 44 1253 629600
- E-mail: mspears001@dundee.ac.uk
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Chercheur principal:
- Mark Spears, PhD FRCP
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Dundee, Royaume-Uni, DD21UB
- Recrutement
- Ninewells Hospital
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Chercheur principal:
- Mark Spears, PhD FRCP
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Contact:
- Mark Spears, PhD FRCP
- Numéro de téléphone: 44 1382 660111
- E-mail: mspears001@dundee.ac.uk
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Perth, Royaume-Uni, PH1 1NX
- Recrutement
- Perth Royal Infirmary
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Chercheur principal:
- Mark Spears, PhD FRCP
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Contact:
- Mar Spears, PhD FRCP
- Numéro de téléphone: 44 1738 473861
- E-mail: mspears001@dundee.ac.uk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Prediction of subsequent clinical outcomes
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mark Spears, PhD FRCP, NHS Tayside and University of Dundee
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 3-067-24
- Charity (Autre subvention/numéro de financement: British Pigeon Fanciers Medical Research Charity)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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