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Clinical Trials (PDQ®)

  • First Published: 10/9/2008
  • Last Modified: 1/11/2011

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Clinical Trials (PDQ®)

Pilot Study of Metabolic Biomarkers in Patients With Lung Cancer, Participants at High Risk for Developing Lung Cancer, or Healthy Volunteers. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysisUnknownNot specifiedOtherSWWCI-MEDLUNG
MEDLUNG, UKCRN-4682, EU-20862, NCT00899262

Objectives

  1. 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.
  2. To permit identification of specific metabolic biomarkers within FTIR spectra that can distinguish between lung cancer, high-risk, and non-high-risk cases.

Entry 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)

Prior/Concurrent Therapy:

  • Not specified

Patient Characteristics:

  • Not specified

Expected Enrollment

300

Outcomes

Primary Outcome(s)

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

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.

Published Results

Lewis PD, Lewis KE, Ghosal R, et al.: Evaluation of FTIR spectroscopy as a diagnostic tool for lung cancer using sputum. BMC Cancer 10: 640, 2010.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

South West Wales Cancer Institute

Paul Lewis, BSc, PhD, Principal investigator
Ph: 44-1792-295-222
Email: p.d.lewis@swansea.ac.uk

Registry Information
Official Title Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)
Trial Start Date 2008-04-01
Trial Completion Date 2011-04-01 (estimated)
Registered in ClinicalTrials.gov NCT00899262
Date Submitted to PDQ 2008-06-24
Information Last Verified 2009-06-10

Note: The purpose of some clinical studies is to help researchers learn more about how cancer cells grow and how drugs are used in the body. Cells and tissues collected from cancer patients may be used to detect new biomarkers that may be important in diagnosing and treating cancer in the future. The procedure or lab test described in this clinical study is intended to be carried out by clinical oncologists and researchers in carefully structured settings. Individual results obtained from these studies may not be made available to patients.

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