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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596310
Recruitment Status : Active, not recruiting
First Posted : January 16, 2008
Last Update Posted : January 11, 2018
Marty Driesler Cancer Project
Kentucky Lung Cancer Research Program
Information provided by (Responsible Party):
Susanne Arnold, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Other: CT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Early Detection of Lung Cancer in a High-Risk Population Defined by Pulmonary Function Testing, Biomarkers, and Computerized Tomography Scanning
Actual Study Start Date : November 2004
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Screening CT
Other: CT
Screening CT

Primary Outcome Measures :
  1. test validity [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. test feasibility [ Time Frame: 5 years ]
  2. test efficacy [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00596310

United States, Kentucky
Hazard ARH Regional Medical Center
Hazard, Kentucky, United States, 41702
St. Claire Regional Medical Center
Morehead, Kentucky, United States, 40351
Highlands Regional Medical Center
Prestonsburg, Kentucky, United States, 41653
Lake Cumberland Regional Hospital
Somerset, Kentucky, United States, 42501
Sponsors and Collaborators
Susanne Arnold
Marty Driesler Cancer Project
Kentucky Lung Cancer Research Program
Principal Investigator: Susanne Arnold, M.D. University of Kentucky

Additional Information:
Responsible Party: Susanne Arnold, Associate Director for Clinical Translation, University of Kentucky Identifier: NCT00596310     History of Changes
Other Study ID Numbers: MDCP-Lung
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Susanne Arnold, University of Kentucky:
Lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases