This trial is active, not recruiting.

Condition lung cancer
Treatment ct
Sponsor University of Kentucky
Collaborator Marty Driesler Cancer Project
Start date November 2004
End date December 2016
Trial size 1000 participants
Trial identifier NCT00596310, MDCP-Lung


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose screening
Screening CT
Screening CT

Primary Outcomes

test validity
time frame: 5 years

Secondary Outcomes

test feasibility
time frame: 5 years
test efficacy
time frame: 5 years

Eligibility Criteria

Male or female participants from 55 years up to 75 years old.

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.

Additional Information

Official title Early Detection of Lung Cancer in a High-Risk Population Defined by Pulmonary Function Testing, Biomarkers, and Computerized Tomography Scanning
Principal investigator Susanne Arnold, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Kentucky.