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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00898313
First received: May 9, 2009
Last updated: June 23, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Lung Cancer
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Predictors of Lung Cancer Behavior

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • To quantitate the molecular changes during lung cancer development [ Time Frame: After collection of designated samples ] [ Designated as safety issue: No ]

    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:
  • Develop a method to diagnose and stage pre-invasive and invasive lesions [ Time Frame: After collection of designated samples ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples With DNA

Blood, urine, nasal cells, sputum, bronchal epithelial cells, airway tissue, and lung tissue


Estimated Enrollment: 2000
Study Start Date: December 2003
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sample Collection 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People who may have lung cancer.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898313

Contacts
Contact: Vanderbilt Ingram Clinical Trials Information Program 1-800-811-8480

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clinical Trials Information Program    615-811-8480      
Principal Investigator: Pierre Massion, MD         
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clinical Trials Information Program    800-811-8480      
Principal Investigator: Pierre Massion, MD         
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: VICC Clinical Trials Information Program    800-811-8480      
Principal Investigator: Pierre Massion, MD         
Veterans Affairs Medical Center - Nashville Recruiting
Nashville, Tennessee, United States, 37212
Contact: Research Office    615-873-8066      
Contact: Rena Burns, RN    (615) 873-7658    Rena.Burns@va.gov   
Principal Investigator: Pierre Massion, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Pierre P. Massion, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Pierre P. Massion, MD, Associate Professor of Medicine (Allergy, Pulmonary & Critical Care) and Cancer Biology; Pulmonary and Critical Care Medicine Doctor, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00898313     History of Changes
Other Study ID Numbers: VICC THO 0398, P30CA068485, VU-VICC-THO-0398, VU-VICC-030763
Study First Received: May 9, 2009
Last Updated: June 23, 2014
Health Authority: Unites States: Vanderbilt University Human Reserach Protection Program

Keywords provided by Vanderbilt-Ingram Cancer Center:
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 10, 2014