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

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ClinicalTrials.gov Identifier: NCT00898313
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : November 22, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fabien Maldonado, Vanderbilt-Ingram Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment
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

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 Design
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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Predictors of Lung Cancer Behavior
Study Start Date : December 2003
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. To quantitate the molecular changes during lung cancer development [ Time Frame: 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 :
  1. Develop a method to diagnose and stage pre-invasive and invasive lesions [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Blood, urine, nasal cells, sputum, bronchal epithelial cells, airway tissue, and lung tissue

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898313


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

Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: VICC Clinical Trials Information Program    800-811-8480    cip@vanderbilt.edu   
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
National Cancer Institute (NCI)
Investigators
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Study Chair: Fabien Maldonado, MD Vanderbilt-Ingram Cancer Center
More Information
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Additional Information:

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Responsible Party: Fabien Maldonado, Professor of Medicine and Thoracic Surgery, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00898313    
Other Study ID Numbers: VICC THO 0398
P30CA068485 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: November 22, 2023
Last Verified: November 2023
Keywords provided by Fabien Maldonado, Vanderbilt-Ingram Cancer Center:
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases