Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Rate of Moderate to High Arsenic Level in Cases and Controls [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).
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
Sponsors and Collaborators
- Susanne Arnold
- United States Department of Defense
Investigators
- Principal Investigator: Susanne M Arnold, MD, Lucille P. Markey Cancer Center at University of Kentucky
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DOD2011-193
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lung Cancer Cases | Control Subjects |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Period Title: Overall Study | ||
| STARTED | 153 | 367 |
| COMPLETED | 100 | 267 |
| NOT COMPLETED | 53 | 100 |
Baseline Characteristics
| Arm/Group Title | Lung Cancer Cases | Control Subjects | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Total of all reporting groups |
| Overall Participants | 100 | 267 | 367 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
62
|
62
|
62
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
61
61%
|
148
55.4%
|
209
56.9%
|
| Male |
39
39%
|
119
44.6%
|
158
43.1%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
100
100%
|
267
100%
|
367
100%
|
Outcome Measures
| Title | Rate of Moderate to High Arsenic Level in Cases and Controls |
|---|---|
| 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). |
| Time Frame | up to three years |
Outcome Measure Data
| Analysis Population Description |
|---|
| those with adequate toenail arsenic concentrations |
| Arm/Group Title | Lung Cancer Cases | Control Subjects |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Measure Participants | 100 | 267 |
| Median (Inter-Quartile Range) [mcg/dL] |
0.04
|
0.04
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Lung Cancer Cases | Control Subjects | ||
| Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
| Lung Cancer Cases | Control Subjects | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Lung Cancer Cases | Control Subjects | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | 0/267 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Lung Cancer Cases | Control Subjects | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | 0/267 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Susanne Arnold |
|---|---|
| Organization | University of Kentucky |
| Phone | 8592579568 |
| smarno0@uky.edu |
- DOD2011-193