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Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status

Enrolling

Conditions

Lung Cancer

Treatments

Procedure: fine needle aspiration of the lung
Genetic: proteomic profiling analysis
Procedure: Blood draw
Genetic: gene expression microarray analysis
Procedure: thoracentesis
Procedure: fluorescence bronchoscopy with airway biopsy
Procedure: sputum sample
Genetic: comparative genomic hybridization
Procedure: Urine collection
Other: biologic sample preservation procedure
Procedure: nasal brushing

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00898313
P30CA068485 (U.S. NIH Grant/Contract)
VICC THO 0398

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

4,000 participants in 1 patient group

Sample Collection
Treatment:
Procedure: Urine collection
Other: biologic sample preservation procedure
Procedure: fine needle aspiration of the lung
Genetic: proteomic profiling analysis
Genetic: gene expression microarray analysis
Procedure: Blood draw
Genetic: comparative genomic hybridization
Procedure: sputum sample
Procedure: fluorescence bronchoscopy with airway biopsy
Procedure: nasal brushing
Procedure: thoracentesis

Trial contacts and locations

2

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Central trial contact

Vanderbilt Ingram Clinical Trials Information Program

Data sourced from clinicaltrials.gov

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