ew technologies in diagnosing and monitoring lung disease

Not Applicable

Suspended

• Conditions: Respiratory; Pulmonary diseases (COPD, lung cancer, asthma and others)

• Registration Number: ISRCTN16657101
• Lead Sponsor: Hywel Dda University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-07
• Last Update Posted: 20 July 2020
• Study Completion: 2026-02-21

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Subjects: patients with a diagnosis of respiratory disease and eventually healthy control volunteers. These will conform to the following categories.

COPD:
1. Patients suffering from COPD according to current standard criteria
2. Age over 40 years
3. Ex or current smokers of at least 10 pack-years
4. Post bronchodilator FEV1/FVC<0.70 and FEV1<80% predicted

Lung Cancer:
1. Patients referred by their GPs or other specialists with possible diagnosis of lung cancer
2. Have a smoking history, asbestos exposure or other suspicious symptoms including breathlessness, chest pain, cough, weight loss or exhibits an abnormal chest X-ray

Healthy Controls:
1. Spouses and family members of COPD patients
2. Smokers attending our secondary care smoking cessation service
3. No symptoms or known diagnoses of lung disease.

Patients with lung disease other than COPD or Lung Cancer: depending on resources the study will be expanded to include other controls with asthma, bronchiectasis, fibrosis or lung other diseases.

Exclusion Criteria

No exclusion criteria have been defined, except for the good condition of collected samples and reliability of the information provided to the reseachers by the particiapants.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Sensitivity and specificity of metabolomics screening (sputum, blood and urine) of diagnosing lung cancer (clinical-pathological diagnosis at 12 months) versus age matched controls area under the curve (AUC) analysis at baseline<br> 2. Sensitivity and specificity of metabolomics screening (sputum, blood and urine) of diagnosing COPD (defined using clinical GOLD criteria) versus age matched controls i.e. area under the curve (AUC) analysis at baseline<br>

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures