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

GENETIC

comparative genomic hybridization

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

GENETIC

gene expression microarray analysis

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

GENETIC

proteomic profiling analysis

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

OTHER

biologic sample preservation procedure

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

PROCEDURE

nasal brushing

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

PROCEDURE

Blood draw

Venous blood will be collected

PROCEDURE

Urine collection

Subjects will be asked to provide a urine specimen.

PROCEDURE

sputum sample

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

PROCEDURE

fluorescence 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.

PROCEDURE

fine 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.

PROCEDURE

thoracentesis

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.

To quantitate the molecular changes during lung cancer development

Time frame: After collection of designated samples

As a part of the study nasal brushing specimens, sputum, blood, urine, and a small amount of other tissue will be collected during standard of care procedures (bronchial epithelial, trans-thoracic fine needle aspiration (FNA) and thoracentesis as part of patient work up. Clinical diagnosis is the primary goal of the procedure. All the research specimens are collected after the primary goal of the procedure is met.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.