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

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ClinicalTrials.gov Identifier: NCT00899262
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 12, 2009
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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).

Condition or disease Intervention/treatment
Lung Cancer Tobacco Use Disorder Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: sputum cytology Procedure: Fourier transform infrared spectroscopy Procedure: diagnostic bronchoscopy

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Official Title: Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)
Study Start Date : April 2008
Estimated Primary Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. 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
  2. Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899262

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United Kingdom
Prince Philip Hospital Recruiting
Llanelli, Wales, United Kingdom, SA14 8QF
Contact: Contact Person    44-1554-75-65-67      
South West Wales Cancer Institute Recruiting
Swansea, Wales, United Kingdom, SA2 8PP
Contact: Paul D. Lewis, BSc, PhD    44-1792-295-222    p.d.lewis@swansea.ac.uk   
Sponsors and Collaborators
South West Wales Cancer Institute
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Principal Investigator: Paul D. Lewis, BSc, PhD Swansea University
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00899262    
Other Study ID Numbers: CDR0000599372
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: June 2009
Keywords provided by National Cancer Institute (NCI):
lung cancer
tobacco use disorder
Additional relevant MeSH terms:
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Lung Neoplasms
Tobacco Use Disorder
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders