RecruitingNCT00898313

Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer

Molecular Predictors of Lung Cancer Behavior

Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

4,000 participants

Start Date

Dec 1, 2003

Study Type

OBSERVATIONAL

Conditions

Lung Cancer

Summary

RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.

Exclusion Criteria3

Inability to provide informed consent
Minors
Pregnant women

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Interventions

GENETICcomparative genomic hybridization

Collection of sputum, blood, urine, and a small amount of lung tissue.

GENETICgene expression microarray analysis

Collection of sputum, blood, urine, and a small amount of lung tissue.

GENETICproteomic profiling analysis

Collection of sputum, blood, urine, and a small amount of lung tissue.

OTHERbiologic sample preservation procedure

Collection of sputum, blood, urine, and a small amount of lung tissue.

PROCEDUREnasal brushing

Using a brush, superficial cells are removed from the nose.

PROCEDUREBlood draw

Venous blood will be collected

PROCEDUREUrine collection

Subjects will be asked to provide a urine specimen.

PROCEDUREsputum sample

Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up.

PROCEDUREfluorescence bronchoscopy with airway biopsy

A flexible tube attached to a fluorescent light source will be inserted into the subject's mouth or nose to reach the airway. Samples of the lining of the airway will be taken, as well as bronchial secretions and epithelial cell from brushings of the lining of the airway.

PROCEDUREfine needle aspiration of the lung

A small needle is inserted into the lung to collect tissue. This procedure will only be performed if the patient's physician orders it.

PROCEDUREthoracentesis

A small needle is inserted into the patient's lung cavity and a small amount of fluid is collected. This procedure will only be performed if the patient's physician orders it.