Clinical trial NCT00596310: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
screening
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Marty Driesler Cancer Project
name: Kentucky Lung Cancer Research Program
First posted: 2008-01-16
Enrollment: 531
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: test validity
timeFrame: 5 years
Secondary outcomes:
measure: test feasibility
timeFrame: 5 years
measure: test efficacy
timeFrame: 5 years
Other outcomes:
Locations:
city: Hazard
country: United States
facility: Hazard ARH Regional Medical Center
state: Kentucky
city: Morehead
country: United States
facility: St. Claire Regional Medical Center
state: Kentucky
city: Prestonsburg
country: United States
facility: Highlands Regional Medical Center
state: Kentucky
city: Somerset
country: United States
facility: Lake Cumberland Regional Hospital
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Susanne Arnold, M.D.
role: PRINCIPAL_INVESTIGATOR
References: