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

Official title

Molecular Predictors of Lung Cancer Behavior

Overview

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.

Detailed 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.

Interventions

• Genetic comparative genomic hybridization
  Collection of sputum, blood, urine, and a small amount of lung tissue.
• Genetic gene expression microarray analysis
  Collection of sputum, blood, urine, and a small amount of lung tissue.
• Genetic proteomic profiling analysis
  Collection of sputum, blood, urine, and a small amount of lung tissue.
• Other biologic sample preservation procedure
  Collection of sputum, blood, urine, and a small amount of lung tissue.
• Procedure nasal brushing
  Using a brush, superficial cells are removed from the nose.
• Procedure Blood draw
  Venous blood will be collected
• Procedure Urine collection
  Subjects will be asked to provide a urine specimen.
• Procedure sputum sample
  Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up.
• Procedure 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.
• Procedure 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.

Primary outcome measures

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

Secondary outcome measures (1)

• Develop a method to diagnose and stage pre-invasive and invasive lesions [Time frame: After collection of designated samples]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 2 centers

• Vanderbilt-Ingram Cancer Center — Nashville
• Veterans Affairs Medical Center - Nashville — Nashville

Identifiers

NCT: NCT00898313 · VICC THO 0398 · P30CA068485

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗