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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susanne Arnold, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01648166
First received: April 16, 2012
Last updated: September 5, 2014
Last verified: September 2014

April 16, 2012
September 5, 2014
January 2012
October 2015   (final data collection date for primary outcome measure)
rate of moderate to high arsenic level in cases and controls [ Time Frame: up to three years ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01648166 on ClinicalTrials.gov Archive Site
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A Population-based Case-control 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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood, live lymphocytes, serum, plasma, radon test kit, urine, water, soil, toenails, and hair.

Probability Sample

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.

Lung Cancer
Not Provided
  • lung cancer cases
    subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky
  • control subjects
    subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1800
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01648166
W81XWH-11-1-0781
Yes
Susanne Arnold, University of Kentucky
University of Kentucky
Department of Defense
Principal Investigator: Susanne M Arnold, MD Lucille P. Markey Cancer Center at University of Kentucky
University of Kentucky
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP