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OpenTrials
Completed

NCT Number: NCT00899457

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

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.

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Key information

Conditions

Healthy, no Evidence of Disease Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

proteomic profiling

Genetic

Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath

biologic sample preservation procedure

Other

Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath

laboratory biomarker analysis

Other

Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath

Bronchoscopy

Procedure

Collection of breath condensate.

Primary outcomes

  1. Collection of biological specimens to use as controls in the study of lung cancer progression

    Time frame: Off study date, up to one year

    Specimens are collected from healthy participants with no known risk of lung cancer

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Molecular Predictors of Lung Cancer Behavior: Controls

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 12, 2009
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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