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

Recruiting

• Conditions: Lung Cancer
• Interventions: Genetic: comparative genomic hybridization; Genetic: gene expression microarray analysis; Genetic: proteomic profiling analysis; Other: biologic sample preservation procedure; Procedure: nasal brushing; Procedure: Blood draw; Procedure: Urine collection; Procedure: sputum sample; Procedure: fluorescence bronchoscopy with airway biopsy; Procedure: fine needle aspiration of the lung; Procedure: thoracentesis

• Registration Number: NCT00898313
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sample Collection	gene expression microarray analysis	-
Sample Collection	sputum sample	-
Sample Collection	fine needle aspiration of the lung	-
Sample Collection	thoracentesis	-
Sample Collection	proteomic profiling analysis	-
Sample Collection	biologic sample preservation procedure	-
Sample Collection	fluorescence bronchoscopy with airway biopsy	-
Sample Collection	comparative genomic hybridization	-
Sample Collection	nasal brushing	-
Sample Collection	Blood draw	-
Sample Collection	Urine collection	-

Primary Outcome Measures

Name	Time	Method
To quantitate the molecular changes during lung cancer development	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 Outcome Measures

Name	Time	Method
Develop a method to diagnose and stage pre-invasive and invasive lesions	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

Trial Locations

Locations (2)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Veterans Affairs Medical Center - Nashville; 🇺🇸 Nashville, Tennessee, United States