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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00899028

Collaborator

National Cancer Institute (NCI) (NIH)

689

Enrollment

Locations

183

Duration (Months)

172.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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

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 Design

Study Type:

Observational

Actual Enrollment :

689 participants

Official Title:

Identification and Validation of Molecular Markers in Lung Cancer

Study Start Date :

May 1, 2001

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2016

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee	United States	37064
2	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee	United States	37064
3	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee	United States	37212
4	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838