A Population-based Case-control Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens
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|ClinicalTrials.gov Identifier: NCT01648166|
Recruitment Status : Active, not recruiting
First Posted : July 24, 2012
Last Update Posted : July 13, 2017
|Condition or disease|
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|
|Estimated Enrollment :||1800 participants|
|Official Title:||A Population-based Case-control Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2020|
lung cancer cases
subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky
subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky
- rate of moderate to high arsenic level in cases and controls [ Time Frame: up to three years ]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).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648166
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Susanne M Arnold, MD||Lucille P. Markey Cancer Center at University of Kentucky|