Fluorescence Bronchoscopy and Molecular Characterization of Abnormal Bronchial Lesions: Novel Approaches for Early Detection of Lung Cancer in High Risk Patients
Condition: Cancer
Study type: Observational

Summary: 
      Despite intensive research efforts, there are still no simple and effective screening tools
      to detect early lung cancer. The majority of newly diagnosed patients have higher stage,
      often disseminated, non-resectable disease. A better understanding of the natural biology and
      molecular abnormalities in early lung lesions may aid in the development of more effective
      screening tools. This study will investigate the effectiveness of bronchoscopy by white light
      (WL) alone and in combination with Lung Imaging Fluorescence Endoscopy (LIFE) for the
      detection of early lung lesions in patients with a high risk for developing lung cancer. LIFE
      is a FDA approved adjunct to WL bronchoscopy for the screening of lung cancer and this study
      will provide a standardized setting in which a direct comparison between a combination of WL
      and LIFE versus traditional WL bronchoscopy can be made.

      In addition, the study will set the stage for the collection of a unique set of biopsy
      specimens that will be used to learn more about the natural biology and the molecular changes
      in early lung lesions. We will study abnormalities in p53 by immunohistochemistry and by
      molecular analyses. The p53 results will be compared with histological grade and with genomic
      instability. Measures for genomic instability will be the loss of chromosomal information and
      cellular aneuploidy. Recent advances in molecular pathology, such as the development of Laser
      Capture Microdissection (LCM), have made the molecular profiling of these extremely small
      lesions feasible. The information obtained by these techniques will be used for comparison
      with clinical and exposure information. Future plans include the culturing of bronchial
      epithelial cells to study genomic instability in the multistep process of cancer progression.
      It is our hope that the application of these new technologies will improve the early
      detection of human lung cancer and provide insight into the natural biology and molecular
      changes of early lung lesions which may progress towards overt cancers.
    

Detailed description: 
      Despite intensive research efforts, there are still no simple and effective screening tools
      to detect early lung cancer. The majority of newly diagnosed patients have higher stage,
      often disseminated, non-resectable disease. A better understanding of the natural biology and
      molecular abnormalities in early lung lesions may aid in the development of more effective
      screening tools. The Lung Imaging Fluorescence Endoscopy (LIFE) is FDA approved as an adjunct
      to WL bronchoscopy for the screening of lung cancer.

      Using the LIFE unit, this study will set the stage for the collection of a unique set of
      biopsy specimens that will be used to learn more about the natural biology and molecular
      changes in early lung lesions. We will study abnormalities in p53 by immunohistochemistry and
      by molecular analyses. The p53 results will be compared with histological grade and with
      genomic instability. Measures for genomic instability will be the loss of chromosomal
      information and cellular aneuploidy. Recent advances in molecular pathology, such as the
      development of Laser Capture Microdissection (LCM), have made the molecular profiling of
      these extremely small lesions feasible. The information obtained by these techniques will be
      used for comparison with clinical and exposure information. Future plans include the
      culturing of bronchial epithelial cells to study genomic instability in the multistep process
      of cancer progression. It is our hope that the application of these new technologies will
      improve the early detection of human lung cancer and provide insight into the natural biology
      and molecular changes of early lung lesions which may progress towards overt cancers.
    

Observational model: Case-Control
Time perspective: Prospective
Keywords: Cancer; Lymphocytes; Genetics