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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

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date November 22, 2023
Study Start Date December 2003
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2013)		 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.
Original Primary Outcome Measures
 (submitted: May 9, 2009)		 Use of genetic and proteomic analysis of biological samples to distinguish invasive, pre-invasive carcinoma, and non-cancerous lesions
Change History
Current Secondary Outcome Measures
 (submitted: February 22, 2013)		 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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer
Official Title Molecular Predictors of Lung Cancer Behavior
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, urine, nasal cells, sputum, bronchal epithelial cells, airway tissue, and lung tissue
Sampling Method Non-Probability Sample
Study Population People who may have lung cancer.
Condition Lung Cancer
Intervention
  • 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.
Study Groups/Cohorts Sample Collection
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 21, 2023)		 4000
Original Estimated Enrollment
 (submitted: May 9, 2009)		 300
Estimated Study Completion Date January 31, 2025
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Vanderbilt Ingram Clinical Trials Information Program 1-800-811-8480
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00898313
Other Study ID Numbers VICC THO 0398
P30CA068485 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Fabien Maldonado, Vanderbilt-Ingram Cancer Center
Original Responsible Party Not Provided
Current Study Sponsor Vanderbilt-Ingram Cancer Center
Original Study Sponsor Same as current
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Fabien Maldonado, MD Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt-Ingram Cancer Center
Verification Date November 2023