Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants

April 19, 2017 updated by: Pierre P. Massion, Vanderbilt University Medical Center

Identification and Validation of Molecular Markers in Lung Cancer

RATIONALE: Studying samples of tissue, blood, sputum, and urine from patients with lung cancer and from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers for lung cancer using tissue samples from patients with lung cancer and from healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.
  • To determine the prevalence of candidate biomarkers in lung cancer progression.
  • To determine the odds of developing lung cancer according to biomarker status in preinvasive lesions.
  • To determine the odds of developing lung cancer according to proteomic biomarker status in the normal bronchial epithelium of high-risk patients.

OUTLINE: This is a multicenter study.

Tissue samples are collected at the time of fluorescence bronchoscopy for laboratory biomarker studies. Blood, sputum, and urine samples are also collected. Gene and protein expression studies are performed on the samples using comparative genomic hybridization array, 3q oligonucleotide microarray, matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF), fluorescence in situ hybridization (FISH), and immunohistochemistry (IHC).

Patients' medical records are reviewed to collect information about the patient's past medical history and pertinent laboratory and radiography results.

Patients and healthy volunteers are followed annually via telephone or a mailed questionnaire.

Study Type

Observational

Enrollment (Actual)

689

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 States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37212
        • Veterans Affairs Medical Center - Nashville
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center at Franklin

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

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Known or previously diagnosed lung cancer

    • Suspected lung cancer, including the following:

      • Completely resected stage I lung cancer (with no evidence of metastatic disease) for which patient is at risk for developing secondary disease
      • Suspected of having lung cancer due to clinical symptoms, such as positive sputum cytology, hemoptysis, unresolved pneumonia, persistent cough, and positive x-ray
    • Healthy volunteer

PATIENT CHARACTERISTICS:

  • WBC ≥ 2,000/mm³ but ≤ 20,000/mm³
  • Platelet count ≥ 50,000/mm³
  • Not pregnant
  • No uncontrolled hypertension (i.e., systolic blood pressure > 200 mm Hg, diastolic blood pressure > 120 mm Hg)
  • No unstable angina
  • No known bleeding disorder
  • No other contraindications for white light bronchoscopic examination
  • No other contraindications for fluorescence examination

PRIOR CONCURRENT THERAPY:

  • More than 3 months since prior fluorescent photosensitizing agents (hematoporphyrin derivatives)
  • More than 3 months since prior and no concurrent chemopreventative drugs (e.g., tretinoin)
  • More than 6 months since prior ionizing radiation treatment to the chest
  • More than 6 months since prior systemic cytotoxic chemotherapy
  • No concurrent anticoagulant therapy

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
Identification of new molecular markers specific to the development of squamous cell lung cancer
Prevalence of candidate biomarkers in lung cancer progression
Odds of developing lung cancer according to biomarker status

Collaborators and Investigators

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

Sponsor

Vanderbilt University Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center

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

May 1, 2001

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2016

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 (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000584223
  • P30CA068485 (U.S. NIH Grant/Contract)
  • R01CA102353 (U.S. NIH Grant/Contract)
  • VU-VICC-THO-0373
  • VU-VICC-010178

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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