Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers

Brief Summary

Official Title: “Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)”

RATIONALE: Collecting and storing samples of sputum and tissue to study in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking samples of sputum and tissue from lung cancer patients, participants at high risk for developing lung cancer, and from healthy volunteers (both smokers and non-smokers).

  • Study Type: Observational
  • Study Design: N/A
  • Study Primary Completion Date: April 2011

Detailed Clinical Trial Description


- To test and make a preliminary assessment of the sensitivity and specificity of Fourier transform infrared technology (FTIR) for use in the early detection of lung cancer in sputum samples from patients who have or participants at high risk for developing lung cancer and from non-high-risk smoking and non-smoking volunteers.

- To permit identification of specific metabolic biomarkers within FTIR spectra that can distinguish between lung cancer, high-risk, and non-high-risk cases.

OUTLINE: This is a multicenter study.

Sputum samples and endobronchial biopsy tissue specimens are collected prior to routine bronchoscopy as part of a standard clinical assessment for the early detection of lung cancer. Sputum samples are examined for levels of bronchial and non-bronchial cells using established cytological and immunohistochemical procedures. Samples are also examined for metabolic biomarkers using Fourier transform infrared spectroscopy (FTIR) to generate complete metabolic fingerprints (i.e., spectra) that can distinguish metabolic differences between cancer, non-cancer, and early disease (i.e., dysplasia or metaplasia). These molecular biomarkers, which are detected within FTIR spectra, may be further analyzed in matched endobronchial biopsy tissue samples for histological confirmation. Additional clinico-pathological data is collected for each participant to allow development of predictive statistical models from the data.

All study participants are followed annually.

Interventions Used in this Clinical Trial

  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Other: sputum cytology
  • Procedure: Fourier transform infrared spectroscopy
  • Procedure: diagnostic bronchoscopy

Outcome Measures for this Clinical Trial

Primary Measures

  • Development of a cost-effective, high-throughput, and non-invasive screening test using Fourier transform infrared technology for detection of early lung cancer in sputum of high-risk people
    • Safety Issue?: No
  • Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages
    • Safety Issue?: No

Criteria for Participation in this Clinical Trial


  • Meets 1 of the following criteria:
  • Diagnosis of lung cancer
  • At high risk for developing lung cancer
  • Non-high-risk smoking or non-smoking volunteer (control)


  • Not specified


  • Not specified

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • South West Wales Cancer Institute
  • Overall Official(s)
    • Paul D. Lewis, BSc, PhD, Principal Investigator, Swansea University

Citations Reporting on Results

Lewis PD, Lewis KE, Ghosal R, Bayliss S, Lloyd AJ, Wills J, Godfrey R, Kloer P, Mur LA. Evaluation of FTIR spectroscopy as a diagnostic tool for lung cancer using sputum. BMC Cancer. 2010 Nov 23;10:640. doi: 10.1186/1471-2407-10-640.


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