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Early Detection of Lung Cancer in a High-Risk Population Defined by PFT, Biomarkers, and CT Scanning
NCT00596310 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00596310
The ClinicalTrials.gov registry entry for NCT00596310 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 531 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Susanne Arnold, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00596310 reports 4 study locations spanning 1 distinct geographic area — top geographies include Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00596310?
The interventions under investigation include: CT (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00596310?
This trial is sponsored by Susanne Arnold, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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