Early Detection of Lung Cancer in a High-Risk Population Defined by PFT, Biomarkers, and CT Scanning
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer focused on measuring Lung cancer, screening
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.
Sites / Locations
- Hazard ARH Regional Medical Center
- St. Claire Regional Medical Center
- Highlands Regional Medical Center
- Lake Cumberland Regional Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Screening CT
Outcomes
Primary Outcome Measures
test validity
Secondary Outcome Measures
test feasibility
test efficacy
Full Information
NCT ID
NCT00596310
First Posted
January 7, 2008
Last Updated
February 11, 2020
Sponsor
Susanne Arnold
Collaborators
Marty Driesler Cancer Project, Kentucky Lung Cancer Research Program
1. Study Identification
Unique Protocol Identification Number
NCT00596310
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 Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 2004 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susanne Arnold
Collaborators
Marty Driesler Cancer Project, Kentucky Lung Cancer Research Program
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
531 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Screening CT
Intervention Type
Other
Intervention Name(s)
CT
Intervention Description
Screening CT
Primary Outcome Measure Information:
Title
test validity
Time Frame
5 years
Secondary Outcome Measure Information:
Title
test feasibility
Time Frame
5 years
Title
test efficacy
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Arnold, M.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hazard ARH Regional Medical Center
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41702
Country
United States
Facility Name
St. Claire Regional Medical Center
City
Morehead
State/Province
Kentucky
ZIP/Postal Code
40351
Country
United States
Facility Name
Highlands Regional Medical Center
City
Prestonsburg
State/Province
Kentucky
ZIP/Postal Code
41653
Country
United States
Facility Name
Lake Cumberland Regional Hospital
City
Somerset
State/Province
Kentucky
ZIP/Postal Code
42501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Detection of Lung Cancer in a High-Risk Population Defined by PFT, Biomarkers, and CT Scanning
We'll reach out to this number within 24 hrs