Trial Information

Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)

OBJECTIVES:

- 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.