Lung Cancer
Conditions
Keywords
lung cancer
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.
Interventions
PROCEDUREUrine collection
Subjects will be asked to provide a urine specimen.
PROCEDUREnasal brushing
Using a brush, superficial cells are removed from the nose.
GENETICcomparative genomic hybridization
Collection of sputum, blood, urine, and a small amount of lung tissue.
GENETICgene expression microarray analysis
Collection of sputum, blood, urine, and a small amount of lung tissue.
GENETICproteomic profiling analysis
Collection of sputum, blood, urine, and a small amount of lung tissue.
OTHERbiologic sample preservation procedure
Collection of sputum, blood, urine, and a small amount of lung tissue.
PROCEDUREBlood draw
Venous blood will be collected
PROCEDUREsputum sample
Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up.
PROCEDUREfluorescence 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.
PROCEDUREfine 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.
PROCEDUREthoracentesis
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.
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To quantitate the molecular changes during lung cancer development | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Develop a method to diagnose and stage pre-invasive and invasive lesions | After collection of designated samples | 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 |
Countries
United States
Contacts
Primary ContactVanderbilt Ingram Clinical Trials Information Program
Outcome results
None listed