Recruiting

Observational Study

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT00898313

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

comparative genomic hybridization

gene expression microarray analysis

proteomic profiling analysis

biologic sample preservation procedure

nasal brushing

Study Details

Brief summary:

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.

Conditions

Lung Cancer

Study ID

NCT00898313

Start date

Dec, 2003

Status verified date

Apr, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

4000 participants

Anticipated

Interventions and Outcome Measures

Arms

Sample Collection

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Vanderbilt Ingram Clinical Trials Information Program

1-800-811-8480

Locations

Vanderbilt-Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

VICC Clinical Trials Information Program

800-811-8480cip@vanderbilt.edu

Principal Investigator:

Pierre Massion, MD

Veterans Affairs Medical Center - Nashville

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Research Office

615-873-8066

Rena Burns, RN

(615) 873-7658Rena.Burns@va.gov

Principal Investigator:

Pierre Massion, MD

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • lung cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2026-04-27.