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Spots Global Cancer Trial Database for Early Detection of Lung Cancer in a High-Risk Population Defined by PFT, Biomarkers, and CT Scanning

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Trial Identification

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

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

Study ID: NCT00596310

Conditions

Lung Cancer

Interventions

CT

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 55 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Hazard ARH Regional Medical Center, Hazard, Kentucky, United States

St. Claire Regional Medical Center, Morehead, Kentucky, United States

Highlands Regional Medical Center, Prestonsburg, Kentucky, United States

Lake Cumberland Regional Hospital, Somerset, Kentucky, United States

Contact Details

Name: Susanne Arnold, M.D.

Affiliation: University of Kentucky

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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