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

This observational study is looking for molecular changes that happen as lung cancer develops. Researchers are collecting samples like blood, urine, sputum (mucus from your lungs), and a small amount of lung tissue from people at high risk for lung cancer. They will use genetic tests, such as comparative genomic hybridization and gene expression microarray analysis, and proteomic profiling analysis (studying proteins) on these samples. The goal is to find biomarkers (signs in your body) that can help doctors better understand and potentially diagnose lung cancer earlier. You may be eligible if you are an adult referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital, or Meharry Medical Center for lung cancer evaluation.

Study design
This is an observational study with a planned enrollment of 4000 participants. It is not a treatment study but focuses on collecting and analyzing biological samples.
What's involved
You would provide samples of blood, urine, nasal cells (collected with a brush), sputum, and a small amount of lung tissue (collected during a procedure called fluorescence bronchoscopy).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, which is to measure molecular changes, is assessed after the collection of designated samples.

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NCT00898313

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

Recruiting
Not specifiedAges 18+Observational
Vanderbilt-Ingram Cancer Center
~4,000 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:comparative genomic hybridizationgene expression microarray analysisproteomic profiling analysisbiologic sample preservation procedurenasal brushingBlood draw

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To quantitate the molecular changes during lung cancer development
Measured over After collection of designated samples
Lung Cancer
2 sites across 1 states
Tennessee2
  • Fabien Maldonado, MD · STUDY_CHAIR · Vanderbilt-Ingram Cancer Center
Vanderbilt Ingram Clinical Trials Information Program
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Eligibility criteria

Inclusion

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

Inability to provide informed consent
Minors
Pregnant women
  • To quantitate the molecular changes during lung cancer developmentAfter 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.