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

August 23, 2013 updated by: South West Wales Cancer Institute

Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Llanelli, Wales, United Kingdom, SA14 8QF
        • Recruiting
        • Prince Philip Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1554-75-65-67
      • Swansea, Wales, United Kingdom, SA2 8PP
        • Recruiting
        • South West Wales Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South West Wales Cancer Institute

Investigators

  • Principal Investigator: Paul D. Lewis, BSc, PhD, Swansea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000599372
  • SWWCI-MEDLUNG
  • UKCRN-4682
  • EU-20862

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tobacco Use Disorder

  • University of California, San Francisco
    Tobacco Related Disease Research Program
    Recruiting
    Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness (EXIT)
    Tobacco Cessation | Tobacco Use | Tobacco Use Cessation | Tobacco Dependence | Tobacco Abstinence
    United States
  • Washington University School of Medicine
    National Cancer Institute (NCI); National Institutes of Health (NIH)
    Completed
    Helping Poor Smokers Quit
    Smoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Nicotine Dependence | Tobacco Dependence | Smoking, Tobacco | Nicotine Use Disorder | Nicotine Dependence, Cigarettes | Smoking, Cigarette | Nicotine Dependence Tobacco Product | Tobacco; Use, Rehabilitation | Smoking (Tobacco) Addiction and other conditions
    United States
  • University of Utah
    National Cancer Institute (NCI)
    Recruiting
    Reach Through Equitable Implementation in Utah (REI-UT)
    Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Tobacco Dependence | Tobacco Chewing
    United States
  • Harvard School of Public Health (HSPH)
    Beacon Communities; The Community Builders
    Enrolling by invitation
    Enhancing Equity in Smoke-free Housing
    Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Second Hand Tobacco Smoke
    United States
  • Johns Hopkins University
    National Institute on Drug Abuse (NIDA)
    Recruiting
    Oral Cannabidiol for Tobacco Cessation
    Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence
    United States
  • University of California, San Francisco
    National Institute on Drug Abuse (NIDA); National Institute on Minority Health...
    Completed
    A Facebook Intervention for Young Sexual and Gender Minority Smokers (POP)
    Smoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Smoking, Tobacco | Smoking, Cigarette
    United States
  • University of California, San Francisco
    Tobacco Related Disease Research Program
    Completed
    An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers (POP-6)
    Smoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Smoking, Tobacco | Smoking, Cigarette
    United States
  • Centre for Addiction and Mental Health
    Canadian Cancer Society (CCS)
    Recruiting
    Smoking Cessation and Menstrual Cycle Phase (MC-NRT)
    Smoking Cessation | Tobacco Smoking | Substance Use Disorders | Nicotine Dependence | Nicotine Use Disorder
    Canada
  • Indiana University
    National Institute on Drug Abuse (NIDA)
    Recruiting
    Temporal Interference Methods for Addiction Treatment
    Substance Use Disorders | Nicotine Use Disorder
    United States
  • New York State Psychiatric Institute
    Terminated
    Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment
    Smoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Nicotine Dependence | Cigarette Smoking | Tobacco Dependence | Nicotine Use Disorder | Smoking, Cigarette
    United States

Clinical Trials on laboratory biomarker analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe