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

35 Years
Not Enrolling
Lung Cancer

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Trial Information

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

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.

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.


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

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

Type of Study:


Study Design:


Principal Investigator

Jack Taylor, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Environmental Health Sciences (NIEHS)


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • p53
  • Smoking
  • Carcinogenesis
  • Loss of Heterozygosity
  • Lung Neoplasms



NIEHS, Research Triangle Park Research Triangle Park, North Carolina  27709