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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00899028
First Posted: May 12, 2009
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pierre P. Massion, Vanderbilt University Medical Center
  Purpose

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.


Condition Intervention
Lung Cancer Genetic: comparative genomic hybridization Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: microarray analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry Other: medical chart review Procedure: diagnostic bronchoscopy

Study Type: Observational
Official Title: Identification and Validation of Molecular Markers in Lung Cancer

Resource links provided by NLM:


Further study details as provided by Pierre P. Massion, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • 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

Enrollment: 689
Study Start Date: May 2001
Study Completion Date: August 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899028


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University Medical Center
National Cancer Institute (NCI)
Investigators
Study Chair: Pierre P. Massion, MD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Pierre P. Massion, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00899028     History of Changes
Other Study ID Numbers: CDR0000584223
R01CA102353 ( U.S. NIH Grant/Contract )
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-THO-0373
VU-VICC-010178
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: April 20, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pierre P. Massion, Vanderbilt University Medical Center:
stage 0 non-small cell lung cancer
stage I non-small cell lung cancer
extensive stage small cell lung cancer
limited stage small cell lung cancer
stage II non-small cell lung cancer
stage IV non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases