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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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).
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Mark Spears, PhD FRCP
- Telefonnummer: +44 1738 473861
- E-post: mspears001@dundee.ac.uk
Studiesteder
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Blackpool, Storbritannia, FY1 1HU
- Rekruttering
- Winter Gardens
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Ta kontakt med:
- Mark Spears, PhD FRCP
- Telefonnummer: 44 1253 629600
- E-post: mspears001@dundee.ac.uk
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Hovedetterforsker:
- Mark Spears, PhD FRCP
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Dundee, Storbritannia, DD21UB
- Rekruttering
- Ninewells Hospital
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Hovedetterforsker:
- Mark Spears, PhD FRCP
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Ta kontakt med:
- Mark Spears, PhD FRCP
- Telefonnummer: 44 1382 660111
- E-post: mspears001@dundee.ac.uk
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Perth, Storbritannia, PH1 1NX
- Rekruttering
- Perth Royal Infirmary
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Hovedetterforsker:
- Mark Spears, PhD FRCP
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Ta kontakt med:
- Mar Spears, PhD FRCP
- Telefonnummer: 44 1738 473861
- E-post: mspears001@dundee.ac.uk
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Prediction of subsequent clinical outcomes
Tidsramme: 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
Tidsramme: 5 years
|
The tests employed will be assessed for their ease of performance and acceptability from a participant perspective
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5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mark Spears, PhD FRCP, NHS Tayside and University of Dundee
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 3-067-24
- Charity (Annet stipend/finansieringsnummer: British Pigeon Fanciers Medical Research Charity)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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