NCT00596310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
531

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

12.1 years

First QC Date

January 7, 2008

Last Update Submit

February 11, 2020

Conditions

Lung Cancer

Keywords

Lung cancerscreening

Outcome Measures

Primary Outcomes (1)

  • test validity

    5 years

Secondary Outcomes (2)

  • test feasibility

    5 years

  • test efficacy

    5 years

Study Arms (1)

1

EXPERIMENTAL

Screening CT

Other: CT

Interventions

CTOTHER

Screening CT

1

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hazard ARH Regional Medical Center

Hazard, Kentucky, 41702, United States

Location

St. Claire Regional Medical Center

Morehead, Kentucky, 40351, United States

Location

Highlands Regional Medical Center

Prestonsburg, Kentucky, 41653, United States

Location

Lake Cumberland Regional Hospital

Somerset, Kentucky, 42501, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Susanne Arnold, M.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Director for Clinical Translation

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

November 1, 2004

Primary Completion

December 1, 2016

Study Completion

January 1, 2020

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)