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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: CT

• Study Type: Interventional
• Enrollment (Actual): 531
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Hazard, Kentucky, United States, 41702
      • Hazard ARH Regional Medical Center
    • Morehead, Kentucky, United States, 40351
      • St. Claire Regional Medical Center
    • Prestonsburg, Kentucky, United States, 41653
      • Highlands Regional Medical Center
    • Somerset, Kentucky, United States, 42501
      • Lake Cumberland Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Screening CT	Other: CT; Screening CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
test validity	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
test feasibility	5 years
test efficacy	5 years

Collaborators and Investigators

• Sponsor: Susanne Arnold
• Collaborators: Kentucky Lung Cancer Research Program; Marty Driesler Cancer Project
• Investigators: Principal Investigator: Susanne Arnold, M.D., University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2004
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: January 7, 2008
• First Submitted That Met QC Criteria: January 7, 2008
• First Posted (Estimate): January 16, 2008

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Lung cancer; screening
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: MDCP-Lung

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO