Molecular Predictors of Cancer in Patients at High Risk of 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.

Conditions

• Lung Cancer

Interventions

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.

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.

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Vanderbilt-Ingram Cancer Center

  lead OTHER

Principal Investigators

• Fabien Maldonado, MD · Vanderbilt-Ingram Cancer Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-12-31

Primary Completion

2027-01-31

Completion

2027-01-31

Countries

• United States

Study Locations