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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899262
First received: May 9, 2009
Last updated: August 23, 2013
Last verified: June 2009
  Purpose

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

Study Type: Observational
Official Title: Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]
  • Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2008
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899262

Locations
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
Investigators
Principal Investigator: Paul D. Lewis, BSc, PhD Swansea University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00899262     History of Changes
Other Study ID Numbers: CDR0000599372, SWWCI-MEDLUNG, UKCRN-4682, EU-20862
Study First Received: May 9, 2009
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
lung cancer
tobacco use disorder

Additional relevant MeSH terms:
Lung Neoplasms
Tobacco Use Disorder
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014