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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899028
First received: May 9, 2009
Last updated: August 11, 2009
Last verified: October 2008
  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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Identification of new molecular markers specific to the development of squamous cell lung cancer [ Designated as safety issue: No ]
  • Prevalence of candidate biomarkers in lung cancer progression [ Designated as safety issue: No ]
  • Odds of developing lung cancer according to biomarker status [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: May 2001
Estimated Primary Completion Date: May 2011 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00899028

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: Pierre P Massion    615-322-3412      
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: Pierre P Massion    615-322-3412      
Veterans Affairs Medical Center - Nashville Recruiting
Nashville, Tennessee, United States, 37212
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Nas    615-327-4751      
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Pierre P. Massion, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00899028     History of Changes
Other Study ID Numbers: CDR0000584223, VU-VICC-THO-0373, VU-VICC-010178
Study First Received: May 9, 2009
Last Updated: August 11, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014