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NCT Number: NCT00898313

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

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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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. To quantitate the molecular changes during lung cancer development

    Time frame: After 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.

Secondary outcomes

  1. Develop a method to diagnose and stage pre-invasive and invasive lesions

    Time frame: After collection of designated samples

    Use of proteomic techniques in the laboratory to find a method of diagnosing lung tissue as benign or malignant rather than relying on invasive open-chest surgery for a diagnosis

Study contacts

Contact information is provided by the study sponsor or research team.

Vanderbilt Ingram Clinical Trials Information Program

CONTACT

1-800-811-8480

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Molecular Predictors of Lung Cancer Behavior

Important dates

Study start
2003
Primary completion
2027
Study completion
2027
First posted
May 12, 2009
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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