RecruitingRecruiting
Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer
NCT00898313 · Vanderbilt-Ingram Cancer Center
In plain English
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Official title
Molecular Predictors of Lung Cancer Behavior
About this study
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.
Eligibility criteria
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
Enrollment target: 4000 participants
Age groups: adult, older_adult
Timeline
Starts: 2003-12
Estimated completion: 2027-01-31
Last updated: 2026-04-27
Interventions
Genetic: comparative genomic hybridizationGenetic: gene expression microarray analysisGenetic: proteomic profiling analysisOther: biologic sample preservation procedureProcedure: nasal brushingProcedure: Blood drawProcedure: Urine collectionProcedure: sputum sampleProcedure: fluorescence bronchoscopy with airway biopsyProcedure: fine needle aspiration of the lungProcedure: thoracentesis
Primary outcomes
- • To quantitate the molecular changes during lung cancer development (After collection of designated samples)
Sponsor
Vanderbilt-Ingram Cancer Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactVanderbilt Ingram Clinical Trials Information Program · contact · 1-800-811-8480
InvestigatorFabien Maldonado, MD · study_chair, Vanderbilt-Ingram Cancer Center
All locations (2)
Vanderbilt-Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States
Veterans Affairs Medical Center - NashvilleRecruiting
Nashville, Tennessee, United States