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

NCT00596310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 531

Last updated 2020-02-13

No results posted yet for this study

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.

Conditions

Interventions

OTHER

CT

Screening CT

Sponsors & Collaborators

  • Marty Driesler Cancer Project

    collaborator UNKNOWN

  • Kentucky Lung Cancer Research Program

    collaborator OTHER

  • Susanne Arnold

    lead OTHER

Principal Investigators

  • Susanne Arnold, M.D. · University of Kentucky

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2016-12-31
Completion
2020-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00596310 on ClinicalTrials.gov