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
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|
- 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.
|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|
- 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
- Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages
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
|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 firstname.lastname@example.org|
|Principal Investigator:||Paul D. Lewis, BSc, PhD||Swansea University|