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

Lung Cancer Clinical Trial

Official title:

Molecular Predictors of Lung Cancer Behavior

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00898313
• Other study ID #: VICC THO 0398
• Secondary ID: P30CA068485
• Status: Recruiting
• Start date: December 2003
• Est. completion date: January 31, 2025

Study information

• Verified date: November 2023
• Source: Vanderbilt-Ingram Cancer Center
• Contact: Vanderbilt Ingram Clinical Trials Information Program
• Phone: 1-800-811-8480
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• 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.

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.
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To quantitate the molecular changes during lung cancer development	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.	After collection of designated samples
Secondary	Develop a method to diagnose and stage pre-invasive and invasive lesions	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	After collection of designated samples

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial