Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers
NCT ID: NCT00899262
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2008-04-30
Brief Summary
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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).
Detailed Description
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* 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.
Conditions
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Keywords
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Interventions
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immunohistochemistry staining method
laboratory biomarker analysis
sputum cytology
Fourier transform infrared spectroscopy
diagnostic bronchoscopy
Eligibility Criteria
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Inclusion Criteria
* 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)
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified
ALL
Yes
Sponsors
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South West Wales Cancer Institute
OTHER
Principal Investigators
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Paul D. Lewis, BSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Swansea University
Locations
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Prince Philip Hospital
Llanelli, Wales, United Kingdom
South West Wales Cancer Institute
Swansea, Wales, United Kingdom
Countries
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Facility Contacts
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Contact Person
Role: primary
Paul D. Lewis, BSc, PhD
Role: primary
References
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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.
Other Identifiers
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SWWCI-MEDLUNG
Identifier Type: -
Identifier Source: secondary_id
UKCRN-4682
Identifier Type: -
Identifier Source: secondary_id
EU-20862
Identifier Type: -
Identifier Source: secondary_id
CDR0000599372
Identifier Type: -
Identifier Source: org_study_id