Novel technologies in diagnosing and monitoring lung disease

Application of metabolomics and microbiome sequencing in diagnosing and monitoring lung disease (COPD, Lung cancer, asthma, infections)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16657101

Enrollment

2800

Registered

2017-03-07

Start date

2016-05-12

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary diseases (COPD, lung cancer, asthma and others) Respiratory Pulmonary diseases (COPD, lung cancer, asthma and others)

Interventions

Following provision of written, informed consent, participants attending hospital or their GP for their respiratory condition will be asked questions regarding their age, illness and treatments. They

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 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	—

Measure

Time frame

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 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

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom, Wales

Contacts

Public ContactKeir Lewis

k.e.lewis@swansea.ac.uk+44 1554 783133

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026