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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
OBJECTIVES: To use fixed lung tissue for histological evaluation and fresh tissue samples for molecular studies to study DNA, RNA, and protein abnormalities in lung preneoplastic and neoplastic lesions. To use proteomic techniques, including matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS), to develop a method of diagnosing and staging both pre-invasive and invasive lesions, using less invasive methods. OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection. Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.

Official Title
-----------------
Molecular Predictors of Lung Cancer Behavior

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Genetic: comparative genomic hybridization
* Genetic: gene expression microarray analysis
* Genetic: proteomic profiling analysis
* Other: biologic sample preservation procedure
* Procedure: nasal brushing
* Procedure: Blood draw
* Procedure: Urine collection
* Procedure: sputum sample
* Procedure: fluorescence bronchoscopy with airway biopsy
* Procedure: fine needle aspiration of the lung
* Procedure: thoracentesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -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 Criteria: Inability to provide informed consent Minors Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sample Collection<br> | Genetic: comparative genomic hybridization<br>* Collection of sputum, blood, urine, and a small amount of lung tissue.<br>Genetic: gene expression microarray analysis<br>* Collection of sputum, blood, urine, and a small amount of lung tissue.<br>Genetic: proteomic profiling analysis<br>* Collection of sputum, blood, urine, and a small amount of lung tissue.<br>Other: biologic sample preservation procedure<br>* Collection of sputum, blood, urine, and a small amount of lung tissue.<br>Procedure: nasal brushing<br>* Using a brush, superficial cells are removed from the nose.<br>Procedure: Blood draw<br>* Venous blood will be collected<br>Procedure: Urine collection<br>* Subjects will be asked to provide a urine specimen.<br>Procedure: sputum sample<br>* Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up.<br>Procedure: fluorescence bronchoscopy with airway biopsy<br>* 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.<br>Procedure: fine needle aspiration of the lung<br>* A small needle is inserted into the lung to collect tissue. This procedure will only be performed if the patient's physician orders it.<br>Procedure: thoracentesis<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantitate the molecular changes during lung cancer development | 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. | After collection of designated samples | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop a method to diagnose and stage pre-invasive and invasive lesions | Use of proteomic techniques in the laboratory to find a method of diagnosing lung tissue as benign or malignant rather than relying on invasive open-chest surgery for a diagnosis | After collection of designated samples | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer