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CompletedNCT00899028Updated Apr 20, 2017

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

An observational study in Lung Cancer, sponsored by Vanderbilt University Medical Center. Completed at 4 sites in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-20.

Sponsored by Vanderbilt University Medical Center · Observational

Study type
Observational
Enrollment
689
Ages
18 Years to 120 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer

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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
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's enrollment of 689 is above the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Enrollment
689 participants (actual)

Interventions

  • Geneticcomparative genomic hybridization
  • Geneticfluorescence in situ hybridization
  • Geneticgene expression analysis
  • Geneticmicroarray analysis
  • Geneticprotein expression analysis
  • Otherimmunohistochemistry staining method
  • Otherlaboratory biomarker analysis
  • Othermatrix-assisted laser desorption/ionization time of flight mass spectrometry
  • Othermedical chart review
  • Procedurediagnostic bronchoscopy
06

What researchers measure

Primary outcomes

  1. Identification of new molecular markers specific to the development of squamous cell lung cancer

  2. Prevalence of candidate biomarkers in lung cancer progression

  3. Odds of developing lung cancer according to biomarker status

07

Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00899028
Lead sponsor
Vanderbilt University Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Pierre P. Massion (Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
May 12, 2009
Start date
May 2001
Primary completion
Aug 2015
Completion
Aug 2016
Last update
Apr 20, 2017

Study contacts

Pierre P. Massion, MD
study chair · Vanderbilt-Ingram Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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