Vanderbilt Clinical Trials

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

Purpose

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.

Condition

Lung Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
Sample Collection		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.

Recruiting Locations

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37212

Contact:
VICC Clinical Trials Information Program
800-811-8480
cip@vanderbilt.edu

More Details

Status: Recruiting
Sponsor: Vanderbilt-Ingram Cancer Center

Study Contact

Vanderbilt Ingram Clinical Trials Information Program
1-800-811-8480

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.