A Population-based Case-control Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens
18 Years
N/A
Both
Lung Cancer
Trial Information
A Population-based Case-control Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens
Appalachian Kentucky has one of the highest incidence rates of lung cancer in the United
States. The disproportionately high incidence is not explained by tobacco alone.
Preliminary analysis of trace element content in toenail samples reveals higher levels of
arsenic, chromium and nickel in Appalachian Kentucky residents than elsewhere in Kentucky.
Trace elements are known to promote carcinogenesis by increased oxidative stress,
inflammation, DNA damage, and reduced DNA repair efficiency. These findings justify further
investigation of the role that trace elements play in the development of lung cancer in this
region. Hypothesis: The unexpectedly high rate of lung cancer in Appalachian Kentucky is
associated with exposure to environmental carcinogens that increase oxidative stress and DNA
damage.
Specific Aims Aim 1: Conduct a case-control study of lung cancer and matched controls in the
5th Congressional District of Kentucky to compare rates of moderate to high arsenic in lung
cancer cases and controls.
Aim 2: Create a specimen repository of biologic and environmental samples from these
subjects and their residences for analysis of DNA repair markers and, in the future, markers
of oxidative stress and inflammation.
Aim 3: Fund four pilot projects which will utilize collected data from Aim 1 to develop
investigators focused on lung cancer research in this study population and to generate
preliminary data that will lead to independent funding.
Study Design: This is a population-based, case-control study encompassing the 5th
Congressional District of Kentucky.
Relevance: This translational research and repository will fundamentally improve our
understanding of the causes of the disproportionately high incidence of lung cancer in
Appalachian Kentucky, foster collaboration among scientists dedicated to the study of lung
cancer and provide a permanent resource to be used for future research.
Inclusion Criteria
The following eligibility criteria are required for study entry and participation.
Inclusion (Lung cancer cases):
- Living persons with histologically or cytologically confirmed primary carcinoma of
the lung (International Classification of Diseases-9, 162.2-162.9) between October
17, 2011 and October 16, 2013
- Age greater than 17
- Must be residents of the 5th Congressional District
- No prior history of any cancer (other than stage I and II non-melanomatous skin
cancer)
- Must have a working phone
- Ability to participate in an in-person interview
- English speaking will be eligible for the study (no proxy respondents will be used)
Inclusion (Control cases):
- Age greater than 17
- No prior history of any cancer (other than stage I and II non-melanomatous skin
cancer)
- Must be residents of the 5th Congressional District at the time they are matched to
the case.
- Must have a working phone
- Ability to participate in an in-person interview
- English speaking will be eligible for the study (no proxy respondents will be used)
Exclusion:
- History of any cancers other than those listed above
- Non-residents of the 5th congressional district of Kentucky
- Age 17 years or less
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
rate of moderate to high arsenic level in cases and controls
Outcome Description:
Conduct a case-control study of lung cancer and matched controls in the 5th Congressional District of Kentucky to compare rates of moderate to high arsenic in lung cancer cases and controls (primary endpoint).
Outcome Time Frame:
up to three years
Safety Issue:
No
Principal Investigator
Susanne M Arnold, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Lucille P. Markey Cancer Center at University of Kentucky
Authority:
United States: Federal Government
Study ID:
W81XWH-11-1-0781
NCT ID:
NCT01648166
Start Date:
January 2012
Completion Date:
October 2014
Related Keywords:
- Lung Cancer
- trace
- element
- lung
- cancer
- Appalachia
- Lung Neoplasms
Name | Location |
|---|---|
| University of Kentucky | Lexington, Kentucky 40536-0098 |
