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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mark Spears, PhD FRCP
- Número de teléfono: +44 1738 473861
- Correo electrónico: mspears001@dundee.ac.uk
Ubicaciones de estudio
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Blackpool, Reino Unido, FY1 1HU
- Reclutamiento
- Winter Gardens
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Contacto:
- Mark Spears, PhD FRCP
- Número de teléfono: 44 1253 629600
- Correo electrónico: mspears001@dundee.ac.uk
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Investigador principal:
- Mark Spears, PhD FRCP
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Dundee, Reino Unido, DD21UB
- Reclutamiento
- Ninewells Hospital
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Investigador principal:
- Mark Spears, PhD FRCP
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Contacto:
- Mark Spears, PhD FRCP
- Número de teléfono: 44 1382 660111
- Correo electrónico: mspears001@dundee.ac.uk
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Perth, Reino Unido, PH1 1NX
- Reclutamiento
- Perth Royal Infirmary
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Investigador principal:
- Mark Spears, PhD FRCP
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Contacto:
- Mar Spears, PhD FRCP
- Número de teléfono: 44 1738 473861
- Correo electrónico: mspears001@dundee.ac.uk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prediction of subsequent clinical outcomes
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mark Spears, PhD FRCP, NHS Tayside and University of Dundee
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 3-067-24
- Charity (Otro número de subvención/financiamiento: British Pigeon Fanciers Medical Research Charity)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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