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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Environmental sampling | Other | Soil, water, blood, urine, hair and radon testing in homes in Appalachia |
|
| 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 |
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The following eligibility criteria are required for study entry and participation.
Inclusion (Lung cancer cases):
Inclusion (Control cases):
Exclusion:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Susanne M Arnold, MD | Lucille P. Markey Cancer Center at University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lung Cancer Cases | subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia |
| FG001 | Control Subjects | subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
population with trace element data available from toe nail analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Lung Cancer Cases | subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia |
| BG001 | Control Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | those with adequate toenail arsenic concentrations | Posted | Median | Inter-Quartile Range | mcg/dL | up to three years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lung Cancer Cases | subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susanne Arnold | University of Kentucky | 8592579568 | smarno0@uky.edu |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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Blood, live lymphocytes, serum, plasma, radon test kit, urine, water, soil, toenails, and hair.
subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | only those with adequate toenails could complete the primary outcome measure of arsenic in nail. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky
Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Control Subjects | subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia | 0 | 267 | 0 | 267 |
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| D012140 |
| Respiratory Tract Diseases |