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NCT00596310 · ClinicalTrials.gov registry record · NA
Early Detection of Lung Cancer in a High-Risk Population Defined by PFT, Biomarkers, and CT Scanning
A NA study of Lung Cancer, sponsored by Susanne Arnold.
- Completed
- Registry status
- NA
- Development phase
- 531
- Enrollment target
- 4
- Study locations
NCT00596310: Completed NA study of Lung Cancer, sponsored by Susanne Arnold.
NCT00596310 is a NA study of Lung Cancer that has completed, run by Susanne Arnold. The registered enrollment target is 531 participants, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (43% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00596310, a NA study of Lung Cancer, has completed, sponsored by Susanne Arnold.
- COMPLETED
- Registry status
- NA
- Development phase
- 531 participants
- Enrollment target
- 4
- Study locations
Study Summary
Lung cancer is the number one cancer killer in Kentucky and has a very high incidence within the 5th Congressional District of Kentucky (110.8 cases per 100,000 in period 1996-2000). Surgical removal provides the best chance for cure. Unfortunately, the majority of lung cancer cases are detected in an advanced stage, when surgical resection is impossible. This leads to shorter survival rates and increased mortality rates for lung cancer, increased patient suffering, and greater cost to the healthcare system. Methods that favor earlier detection are therefore crucial for successful treatment. One such method, low-dose spiral computed tomography (CT) is being studied to determine whether its use as a screening method will lead to earlier detection and earlier intervention, perhaps impacting survival and mortality in lung cancer. This method has a modest sensitivity to detect lung cancer, but low specificity, which leads to many false positives and a low negative predictive value. The present study is designed to address both of these limitations by: 1) identifying individuals in the population at highest risk for developing lung cancer (due to smoking habits and decreased pulmonary function) for subsequent CT screening, and 2) performing biomarker testing in conjunction with the CT scan to improve the ability to discern individuals with benign lung nodules from those with malignant tumors. The 5th Congressional District of Kentucky has one of the highest rates of lung cancer in the nation and is an ideal location to test the validity (sensitivity and specificity), feasibility (negative and positive predictive value), and efficacy (stage distribution shift to earlier stage disease, increased survival, and decreased cancer-specific mortality) of these strategies to enhance early detection.
Conditions Studied
Interventions
- OTHER CT
Study Locations (4)
Kentucky
- Hazard ARH Regional Medical Center - Hazard
- St. Claire Regional Medical Center - Morehead
- Highlands Regional Medical Center - Prestonsburg
- Lake Cumberland Regional Hospital - Somerset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 531 participants |
| Start Date | 2004-11 |
| Est. Completion | 2020-01 |
| Phase | NA |
What the finished NCT00596310 record still lists
NCT00596310 is an interventional study that assigns participants to a tested intervention. The registered 531 participants enrollment target is mid-sized for trials with a published cap, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which CT is the first listed.
NCT00596310 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT00596310 about?
NCT00596310 is a clinical study titled "Early Detection of Lung Cancer in a High-Risk Population Defined by PFT, Biomarkers, and CT Scanning". Lung cancer is the number one cancer killer in Kentucky and has a very high incidence within the 5th Congressional District of Kentucky (110.8 cases per 100,000 in period 1996-2000). Surgical removal provides the best chance for cure. Unfortunately, the majority of lung cancer cases are detected in ...
What is the current status of trial NCT00596310?
This trial is currently completed. It is a NA study. The enrollment target is 531 participants. The study started on 2004-11. Estimated completion is 2020-01.
What conditions does trial NCT00596310 study?
This clinical trial studies the following conditions: Lung Cancer.
What interventions are being tested in trial NCT00596310?
The interventions under investigation include: CT (OTHER).
Who is sponsoring clinical trial NCT00596310?
This trial is sponsored by Susanne Arnold, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00596310 being conducted?
This trial has 4 study locations across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00596310's enrollment target sits among peer trials
531 66th of 409 higher than 344 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung 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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