Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer
NCT ID: NCT00898313
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4000 participants
OBSERVATIONAL
2003-12-31
2025-01-31
Brief Summary
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PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.
Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sample Collection
comparative genomic hybridization
Collection of sputum, blood, urine, and a small amount of lung tissue.
gene expression microarray analysis
Collection of sputum, blood, urine, and a small amount of lung tissue.
proteomic profiling analysis
Collection of sputum, blood, urine, and a small amount of lung tissue.
biologic sample preservation procedure
Collection of sputum, blood, urine, and a small amount of lung tissue.
nasal brushing
Using a brush, superficial cells are removed from the nose.
Blood draw
Venous blood will be collected
Urine collection
Subjects will be asked to provide a urine specimen.
sputum sample
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
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
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
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.
Interventions
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comparative genomic hybridization
Collection of sputum, blood, urine, and a small amount of lung tissue.
gene expression microarray analysis
Collection of sputum, blood, urine, and a small amount of lung tissue.
proteomic profiling analysis
Collection of sputum, blood, urine, and a small amount of lung tissue.
biologic sample preservation procedure
Collection of sputum, blood, urine, and a small amount of lung tissue.
nasal brushing
Using a brush, superficial cells are removed from the nose.
Blood draw
Venous blood will be collected
Urine collection
Subjects will be asked to provide a urine specimen.
sputum sample
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
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
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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Minors
* Pregnant women
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Fabien Maldonado
Professor of Medicine and Thoracic Surgery
Principal Investigators
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Fabien Maldonado, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States
Countries
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Central Contacts
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Vanderbilt Ingram Clinical Trials Information Program
Role: CONTACT
Facility Contacts
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Research Office
Role: primary
Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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VICC THO 0398
Identifier Type: -
Identifier Source: org_study_id