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Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00899457
First received: May 9, 2009
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  Purpose

RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about the development of cancer.

PURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer development using tissue samples from healthy participants.


Condition Intervention
Healthy, no Evidence of Disease
Lung Cancer
 Genetic: proteomic profiling
Other: biologic sample preservation procedure
Other: laboratory biomarker analysis
Procedure: bronchoscopy

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Collection of biological specimens to use as controls in the study of lung cancer progression [ Time Frame: Off study date, up to one year ] [ Designated as safety issue: No ]
    Specimens are collected from healthy participants with no known risk of lung cancer


Secondary Outcome Measures:
  • Identification of new molecular abnormalities specific to the development of squamous cell carcinoma of the lung [ Time Frame: off-study date, up to one year ] [ Designated as safety issue: No ]
  • Selection of important genes/proteins differentially expressed between study groups (e.g., normal vs low-grade vs high-grade vs invasive) and between normal smokers vs normal non-smokers [ Time Frame: off-study date, up to one year ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: April 2008
Estimated Study Completion Date: August 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy, non-smokers Genetic: proteomic profiling
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
Other: biologic sample preservation procedure
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
Other: laboratory biomarker analysis
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
Procedure: bronchoscopy
Collection of breath condensate.

Detailed Description:

OBJECTIVES:

  • To obtain biological specimens from healthy participants with no known risk of lung cancer to use as controls in the study of lung cancer progression.
  • To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.

OUTLINE: Serum, urine, sputum, and buccal cell samples are collected. Patients also undergo bronchoscopy for collection of bronchial tissue and bronchial brush samples. The samples are used for genomic and proteomic studies to identify new molecular abnormalities specific to the development of lung cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy, non-smokers.

Criteria

DISEASE CHARACTERISTICS:

  • Healthy participant

    • No history of smoking
    • No history of cancer

PATIENT CHARACTERISTICS:

  • SWOG performance status 0
  • No clinically apparent bleeding diathesis

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899457

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Pierre P. Massion, MD Vanderbilt-Ingram Cancer Center
  More 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: NCT00899457     History of Changes
Other Study ID Numbers: VICC-THO-0734, P50CA090949, P30CA068485, VU-VICC-THO-0734, VICC-THO-0734
Study First Received: May 9, 2009
Last Updated: August 10, 2012
Health Authority: United States: Vanderbilt University Human Research Protection Program

Keywords provided by Vanderbilt-Ingram Cancer Center:
squamous cell lung cancer
non-small cell lung cancer
small cell lung cancer
healthy, no evidence of disease

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 16, 2013