Clinical trial NCT00899028: 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
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 689
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.

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

Primary outcomes:
measure: Identification of new molecular markers specific to the development of squamous cell lung cancer
measure: Prevalence of candidate biomarkers in lung cancer progression
measure: Odds of developing lung cancer according to biomarker status
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Veterans Affairs Medical Center - Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Pierre P. Massion, MD
role: STUDY_CHAIR
References: