What this study is
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.
What's being tested
- comparative genomic hybridization
Intervention · GENETIC
- gene expression microarray analysis
Intervention · GENETIC
- proteomic profiling analysis
Intervention · GENETIC
- biologic sample preservation procedure
Intervention · OTHER
- nasal brushing
Intervention · PROCEDURE
Using a brush, superficial cells are removed from the nose.
- Blood draw
Intervention · PROCEDURE
Venous blood will be collected
- Urine collection
Intervention · PROCEDURE
Subjects will be asked to provide a urine specimen.
- sputum sample
Intervention · PROCEDURE
Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up.
- fluorescence bronchoscopy with airway biopsy
Intervention · PROCEDURE
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.
- fine needle aspiration of the lung
Intervention · PROCEDURE
A small needle is inserted into the lung to collect tissue. This procedure will only be performed if the patient's physician orders it.
- thoracentesis
Intervention · PROCEDURE
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.
All of comparative genomic hybridization, gene expression microarray analysis, proteomic profiling analysis, biologic sample preservation procedure
Collection of sputum, blood, urine, and a small amount of lung tissue.
Study details
- Official title
- Molecular Predictors of Lung Cancer Behavior
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
- Lung Cancer
- Enrolling
- 4,000 people
- Starts
- 2003-12
- Est. completion
- 2027-01-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Inability to provide informed consent
- Minors
- Pregnant women
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openContact for every open site
- Pierre Massion, MD · Principal investigator
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
- VICC Clinical Trials Information Program · Contact800-811-8480cip@vanderbilt.edu
RecruitingVeterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States
- Research Office · Contact615-873-8066
- Rena Burns, RN · Contact(615) 873-7658Rena.Burns@va.gov
Recruiting
Study team
Sponsor
Vanderbilt-Ingram Cancer Center
Study ID VICC THO 0398
Study chair
Fabien Maldonado, MD
Vanderbilt-Ingram Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.