Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer
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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 |
- 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.
- 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 |
People who may have lung cancer.
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| Contact: Vanderbilt INgram Clinical Trials Information Program | 1-800-811-8480 | |
| Contact: Willie Hudson | 615-936-5804 | willie.j.hudson@Vanderbilt.Edu |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Willie Hudson 615-936-5804 | |
| Contact: CTIP 800-811-8480 | |
| Principal Investigator: Pierre Massion, MD | |
| Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Willie Hudson 615-936-5804 | |
| Contact: CTIP 800-811-8480 | |
| Principal Investigator: Pierre Massion, MD | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Willie Hudson 615-936-5804 | |
| Contact: CTIP 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 | |
| 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: | February 22, 2013 |
| 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 May 23, 2013