Clinical trial NCT00899457: Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants
Official title: Molecular Predictors of Lung Cancer Behavior: Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy, no Evidence of Disease
Lung Cancer
Keywords: squamous cell lung cancer
non-small cell lung cancer
small cell lung cancer
healthy, no evidence of disease
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy, non-smokers.

Brief summary: 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.

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 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

Primary outcomes:
measure: Collection of biological specimens to use as controls in the study of lung cancer progression
timeFrame: Off study date, up to one year
Secondary outcomes:
measure: Identification of new molecular abnormalities specific to the development of squamous cell carcinoma of the lung
timeFrame: off-study date, up to one year
measure: 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
timeFrame: off-study date, up to one year
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Pierre P. Massion, MD
role: PRINCIPAL_INVESTIGATOR
References: