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.
調査の概要
状態
条件
詳細な説明
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).
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Mark Spears, PhD FRCP
- 電話番号：+44 1738 473861
- メール：mspears001@dundee.ac.uk
研究場所
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Blackpool、イギリス、FY1 1HU
- 募集
- Winter Gardens
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コンタクト：
- Mark Spears, PhD FRCP
- 電話番号：44 1253 629600
- メール：mspears001@dundee.ac.uk
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主任研究者：
- Mark Spears, PhD FRCP
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Dundee、イギリス、DD21UB
- 募集
- Ninewells Hospital
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主任研究者：
- Mark Spears, PhD FRCP
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コンタクト：
- Mark Spears, PhD FRCP
- 電話番号：44 1382 660111
- メール：mspears001@dundee.ac.uk
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Perth、イギリス、PH1 1NX
- 募集
- Perth Royal Infirmary
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主任研究者：
- Mark Spears, PhD FRCP
-
コンタクト：
- Mar Spears, PhD FRCP
- 電話番号：44 1738 473861
- メール：mspears001@dundee.ac.uk
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Prediction of subsequent clinical outcomes
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Mark Spears, PhD FRCP、NHS Tayside and University of Dundee
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 3-067-24
- Charity (その他の助成金/資金番号：British Pigeon Fanciers Medical Research Charity)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。