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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
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

May 9, 2009
August 10, 2012
April 2008
August 2010   (final data collection date for primary outcome measure)
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
  • Collection of biological specimens from healthy participants with no known risk of lung cancer to use as controls in the study of lung cancer progression [ Designated as safety issue: No ]
  • Identification of new molecular abnormalities specific to the development of squamous cell carcinoma of the lung [ 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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00899457 on ClinicalTrials.gov Archive Site
  • 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 ]
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Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants
Molecular Predictors of Lung Cancer Behavior: Controls

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Healthy, non-smokers.

  • Healthy, no Evidence of Disease
  • Lung Cancer
  • 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.
Healthy, non-smokers
Interventions:
  • Genetic: proteomic profiling
  • Other: biologic sample preservation procedure
  • Other: laboratory biomarker analysis
  • Procedure: bronchoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
37
August 2012
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00899457
VICC-THO-0734, P50CA090949, P30CA068485, VU-VICC-THO-0734, VICC-THO-0734
Not Provided
Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Pierre P. Massion, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP