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NCT00512642 · ClinicalTrials.gov registry record
Fluorescence Bronchoscopy and Molecular Characterization of Abnormal Bronchial Lesions: Novel Approaches for Early Detection of Lung Cancer in High Risk Patients
A clinical trial of Cancer, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 120
- Enrollment target
- 1
- Study location
NCT00512642: Completed study of Cancer, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT00512642 is a study of Cancer that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 120 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00512642, a study of Cancer, has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 120 participants
- Enrollment target
- 1
- Study location
Study 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 lesi
Primary Outcome
histologic or genetic change at follow-up bronchoscopy at 6 or 12 months
Conditions Studied
Study Locations (1)
North Carolina
- NIEHS, Research Triangle Park - Research Triangle Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 1999-07-29 |
| Est. Completion | 2019-11-19 |
What the finished NCT00512642 record still lists
NCT00512642 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT00512642 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00512642 about?
NCT00512642 is a clinical study titled "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 i...
What is the current status of trial NCT00512642?
This trial is currently completed. The enrollment target is 120 participants. The study started on 1999-07-29. Estimated completion is 2019-11-19.
What conditions does trial NCT00512642 study?
This clinical trial studies the following conditions: Cancer.
Who is sponsoring clinical trial NCT00512642?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00512642 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00512642's enrollment target sits among peer trials
120 288th of 615 higher than 321 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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