Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers
Primary Purpose
Lung Cancer, Tobacco Use Disorder
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
immunohistochemistry staining method
laboratory biomarker analysis
sputum cytology
Fourier transform infrared spectroscopy
diagnostic bronchoscopy
Sponsored by
About this trial
This is an observational trial for Lung Cancer focused on measuring lung cancer, tobacco use disorder
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
Sites / Locations
- Prince Philip HospitalRecruiting
- South West Wales Cancer InstituteRecruiting
Outcomes
Primary Outcome 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
Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages
Secondary Outcome Measures
Full Information
NCT ID
NCT00899262
First Posted
May 9, 2009
Last Updated
August 23, 2013
Sponsor
South West Wales Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT00899262
Brief Title
Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers
Official Title
Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)
Study Type
Observational
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
South West Wales Cancer Institute
4. Oversight
5. Study Description
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Tobacco Use Disorder
Keywords
lung cancer, tobacco use disorder
7. Study Design
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
sputum cytology
Intervention Type
Procedure
Intervention Name(s)
Fourier transform infrared spectroscopy
Intervention Type
Procedure
Intervention Name(s)
diagnostic bronchoscopy
Primary Outcome Measure Information:
Title
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
Title
Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul D. Lewis, BSc, PhD
Organizational Affiliation
Swansea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince Philip Hospital
City
Llanelli
State/Province
Wales
ZIP/Postal Code
SA14 8QF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1554-75-65-67
Facility Name
South West Wales Cancer Institute
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8PP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul D. Lewis, BSc, PhD
Phone
44-1792-295-222
Email
p.d.lewis@swansea.ac.uk
12. IPD Sharing Statement
Citations:
PubMed Identifier
21092279
Citation
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.
Results Reference
result
Learn more about this trial
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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