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

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

ArmDescriptionAssigned 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

NCT ID
NCT00898313
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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.