Early Detection of Lung Cancer in a High-Risk Population Defined by PFT, Biomarkers, and CT Scanning



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:55 - 75
Updated:3/23/2019
Start Date:November 2004
End Date:January 2020

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Early Detection of Lung Cancer in a High-Risk Population Defined by Pulmonary Function Testing, Biomarkers, and Computerized Tomography 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 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.


Inclusion Criteria:

- Age 55-75 years old.

- Identification of a primary care physician (can be identified by study staff if
needed).

- FEV1/FVC <70% (GOLD 1 or higher COPD) (poor breathing function).

- > or = 40 pack-year current or former (within the last 10 years) tobacco use (i.e.
heavy cigarette smoking history).

Exclusion Criteria:

- Enrolled in any other lung screening or lung cancer prevention trial.

- Chest CT within the prior 12 months.

- Inability to lie flat with arms raised above the head.

- Current or prior personal history of lung cancer.

- Prior history of cancer within the last five years or currently receiving treatment
for cancer, except adequately treated non-melanomatous skin cancer or in-situ cervical
cancer.

- Life expectancy of less than 5 years.

- Patients requiring supplemental oxygen.

- Inability to give informed consent.
We found this trial at
4
sites
Prestonsburg, Kentucky 41653
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Prestonsburg, KY
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Hazard, Kentucky 41702
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Hazard, KY
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Morehead, Kentucky 40351
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Morehead, KY
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Somerset, Kentucky 42501
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Somerset, KY
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