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

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

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

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

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

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

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center

Study record dates

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: extensive stage small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer; limited stage small cell lung cancer; stage 0 non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• 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