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Better Tests- Improving Diagnostic Accuracy and Prognostication in Interstitial Lung Diseases (Better Tests)

2026年5月22日 更新者：Mark Spears、University of Dundee

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.

研究概览

地位

招聘中

条件

详细说明

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).

研究类型

观察性的

注册 (估计的)

750

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 英国
      • Blackpool、英国、FY1 1HU
        • 招聘中
        • Winter Gardens
        • 接触：
        • 首席研究员：
          • Mark Spears, PhD FRCP
      • Dundee、英国、DD21UB
        • 招聘中
        • Ninewells Hospital
        • 首席研究员：
          • Mark Spears, PhD FRCP
        • 接触：
      • Perth、英国、PH1 1NX
        • 招聘中
        • Perth Royal Infirmary
        • 首席研究员：
          • Mark Spears, PhD FRCP
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Active Pigeon Fanciers, or patients with ILD presenting to clinics or hospital services with severe respiratory failure due to ILD

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Pigeon Fanciers
Active Pigeon Fanciers
Clinic patients with ILD
Patients with established Interstitial Lung Disease attending clinic
Hospital patients with ILD
Patients with established Interstitial Lung Disease admitted due to their condition

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Prediction of subsequent clinical outcomes
大体时间：5 years
The utilised tests will be examined for their ability to accurately predict the subsequent diagnostic label for ILD and clinical behaviour
5 years
Acceptability to participants
大体时间：5 years
The tests employed will be assessed for their ease of performance and acceptability from a participant perspective
5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Dundee

合作者

NHS Tayside
British Pigeon Fanciers Medical Research

调查人员

  • 首席研究员：Mark Spears, PhD FRCP、NHS Tayside and University of Dundee

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月17日

初级完成 (估计的)

2036年1月15日

研究完成 (估计的)

2036年1月15日

研究注册日期

首次提交

2026年5月22日

首先提交符合 QC 标准的

2026年5月22日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 3-067-24
  • Charity (其他赠款/资助编号：British Pigeon Fanciers Medical Research Charity)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Likely we will, but I need to clarify how best to do this. Data will not be available for sharing for several years, allowing time to discuss with sponsor on how to approach (mapping to recognised best practice at that time as likely to evolve)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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