Fluorescence Bronchoscopy and Molecular Characterization of Abnormal Bronchial Lesions: Novel Approaches for Early Detection of Lung Cancer in High Risk Patients
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 35 - 127 |
| Updated: | 2/20/2019 |
| Start Date: | July 29, 1999 |
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.
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.
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.
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.
- INCLUSION CRITERIA:
Previously resected stage I, II and IIIa lung cancers.
Prior head and neck carcinoma.
Bronchogenic carcinoma in a first degree relative.
Smoking history of more than 15 pack-years current or past.
Previously treated for Hodgkin's Disease.
Abnormal sputum cytology with negative radiographs.
EXCLUSION CRITERIA:
Patients with a current clinically detectable lung cancer.
Age lower than 35 years.
Pregnant or possibly pregnant.
Patients with any contraindications to bronchoscopy.
Severe underlying medical conditions such as unstable angina, uncompensated congestive
heart failure, severe airway obstruction (FEV1) less than 0.8 L), or uncontrolled
hypertension.
Patients with a bleeding disorder or patients on anticoagulant therapy.
Use of chemopreventive drugs (retinoids) or photosensitizing agents (hematoporphyrin
derivatives) within 3 months prior to initial bronchoscopy.
Life expectancy less than 3 months.
Patients who received chemotherapy or radiotherapy within 6 months prior to initial
bronchoscopy.
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