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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00898313
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • comparative genomic hybridization — GENETIC
    Collection of sputum, blood, urine, and a small amount of lung tissue.
  • gene expression microarray analysis — GENETIC
    Collection of sputum, blood, urine, and a small amount of lung tissue.
  • proteomic profiling analysis — GENETIC
    Collection of sputum, blood, urine, and a small amount of lung tissue.
  • biologic sample preservation procedure — OTHER
    Collection of sputum, blood, urine, and a small amount of lung tissue.
  • nasal brushing — PROCEDURE
    Using a brush, superficial cells are removed from the nose.
  • Blood draw — PROCEDURE
    Venous blood will be collected
  • Urine collection — PROCEDURE
    Subjects will be asked to provide a urine specimen.
  • sputum sample — 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 — 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 — 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 — 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.

Study Details

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.

Key Dates

Start date
Dec 31, 2003
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
4,000 participants (estimated)

Arms

  • Arm: Sample Collection

Primary Outcome Measure

To quantitate the molecular changes during lung cancer development [ Time Frame: After collection of designated samples ]

Central Contacts

  • Vanderbilt Ingram Clinical Trials Information Program
    1-800-811-8480

Locations (2)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37212
VICC Clinical Trials Information Program
800-811-8480
Pierre Massion, MD (PRINCIPAL_INVESTIGATOR)
Veterans Affairs Medical Center - NashvilleNashvilleTennessee37212
Research Office
615-873-8066
Rena Burns, RN
(615) 873-7658
Pierre Massion, MD (PRINCIPAL_INVESTIGATOR)

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