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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-07-29

Study Completion Date

2019-11-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fluorescent Light Bronchoscopy Plus White Light Bronchoscopy for Early Detection of Lung Cancer

NCT00019201

Head and Neck Cancer Lung Cancer

COMPLETED NA

Surveillance For New Lung Primaries

NCT00205439

Lung Cancer

TERMINATED

Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

NCT01517971

Lung Cancer

COMPLETED

Role of Bronchoscopy in Early Lung Cancer Screening of High Risk Population

NCT02277366

Lung Neoplasms

TERMINATED

Surveillance For New Lung Primaries

NCT00205413

Lung Cancer

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients at increased risk of lung cancer

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

150 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No