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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Marty Driesler Cancer Project
Kentucky Lung Cancer Research Program
Information provided by (Responsible Party):
Susanne Arnold, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00596310
First received: January 7, 2008
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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 Intervention
Lung Cancer
Other: CT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • test validity [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • test feasibility [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • test efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: November 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Screening CT
Other: CT
Screening CT

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596310

Locations
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
University of Kentucky
Marty Driesler Cancer Project
Kentucky Lung Cancer Research Program
Investigators
Principal Investigator: Susanne Arnold, M.D. University of Kentucky
  More Information

Additional Information:
No publications provided

Responsible Party: Susanne Arnold, Associate Director for Clinical Translation, University of Kentucky
ClinicalTrials.gov Identifier: NCT00596310     History of Changes
Other Study ID Numbers: MDCP-Lung
Study First Received: January 7, 2008
Last Updated: August 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Lung cancer
screening

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

ClinicalTrials.gov processed this record on September 14, 2014