Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens

A Population-based Case-control Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens

This is a research study about the relationship between lung cancer and environmental risk factors. The purpose of this study is to try to understand the effects of trace elements such as arsenic and chromium, as well as radon on the development of lung cancer. To do this, the investigators will collect information and environmental and biologic specimens from people who live in Appalachian Kentucky who a) have lung cancer or b) don't have lung cancer and will serve as control subjects. The investigators will create a specimen repository of from these people and their residences to compare differences in many risks factors for cancer. By doing this study, the investigators hope to learn why there are more lung cancers in Kentucky's fifth Congressional District than anywhere else in the nation.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Environmental sampling

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 520

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This case-control study will be performed in Appalachian Kentucky, specifically the 5th Congressional District of Kentucky and will include male and female subjects from the subset of all histologically or cytologically confirmed primary carcinoma of the lung (International Classification of Diseases-9, 162.2-162.9) over the age of 17 years old that occur in the 5th District between October 17, 20011 and November 14, 2013.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lung cancer cases; subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky	Other: Environmental sampling; Soil, water, blood, urine, hair and radon testing in homes in Appalachia
control subjects; subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky	Other: Environmental sampling; Soil, water, blood, urine, hair and radon testing in homes in Appalachia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Moderate to High Arsenic Level in Cases and Controls	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).	up to three years

Collaborators and Investigators

• Sponsor: Susanne Arnold
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Susanne M Arnold, MD, Lucille P. Markey Cancer Center at University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 4, 2019

Study Registration Dates

• First Submitted: April 16, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimate): July 24, 2012

Study Record Updates

• Last Update Posted (Actual): November 7, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: lung; cancer; Appalachia; trace; element
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: DOD2011-193