NCT00898313

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

Molecular Predictors of Lung Cancer Behavior

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2003-12-01
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2009-05-12
• Last updated: 2023-11-22

Locations

2 sites across 1 country: United States