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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
comparative genomic hybridization
fluorescence in situ hybridization
gene expression analysis
microarray analysis
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
matrix-assisted laser desorption/ionization time of flight mass spectrometry
medical chart review
diagnostic bronchoscopy
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt-Ingram Cancer Center - Cool Springs
  • Vanderbilt-Ingram Cancer Center at Franklin
  • Veterans Affairs Medical Center - Nashville
  • Vanderbilt-Ingram Cancer Center

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
May 9, 2009
Last Updated
April 19, 2017
Sponsor
Vanderbilt University Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00899028
Brief Title
Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants
Official Title
Identification and Validation of Molecular Markers in Lung Cancer
Study Type
Observational

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Enrollment
689 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
comparative genomic hybridization
Intervention Type
Genetic
Intervention Name(s)
fluorescence in situ hybridization
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
matrix-assisted laser desorption/ionization time of flight mass spectrometry
Intervention Type
Other
Intervention Name(s)
medical chart review
Intervention Type
Procedure
Intervention Name(s)
diagnostic bronchoscopy
Primary Outcome Measure Information:
Title
Identification of new molecular markers specific to the development of squamous cell lung cancer
Title
Prevalence of candidate biomarkers in lung cancer progression
Title
Odds of developing lung cancer according to biomarker status

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre P. Massion, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center - Cool Springs
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Franklin
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Veterans Affairs Medical Center - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

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

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