Lung CancerNCT01648166
Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens
An observational study of Lung Cancer, run by Susanne Arnold at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Environmental sampling
- How many people
- 520 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 4 Sep 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 13Show fewer
- English speaking will be eligible for the study (no proxy respondents will be used)
- 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)
Who cannot join
- History of any cancers other than those listed above
- Non-residents of the 5th congressional district of Kentucky
- Age 17 years or less
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Environmental sampling
- Keywords
- trace, element, lung, cancer, Appalachia
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental samplingOther
Soil, water, blood, urine, hair and radon testing in homes in Appalachia
| Study group | Role | What they receive |
|---|---|---|
| lung cancer cases | subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky Receives: Other: Environmental sampling | |
| control subjects | subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky Receives: Other: Environmental sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2014
- Study completion4 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Arnold
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Susanne Arnold, University of Kentucky
- Investigators
- Susanne M Arnold, MD, Principal investigator, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648166
- Sponsor's protocol ID
- DOD2011-193
- Status last verified
- Oct 2019
- First submitted
- 16 Apr 2012
- Last updated
- 7 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population-based Case-control Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens
- ClinicalTrials.gov ID
- NCT01648166
- Acronym / sponsor ID
- DOD2011-193
- Conditions
- Lung Cancer
- Keywords
- trace, element, lung, cancer, Appalachia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Susanne ArnoldUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2011 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Posted 7 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lung cancer cases | – | Other: Environmental samplingsubjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky |
| control subjects | – | Other: Environmental samplingsubjects without lung cancer, greater than 17 who reside in Appalachian Kentucky |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- History of any cancers other than those listed above
- Non-residents of the 5th congressional district of Kentucky
- Age 17 years or less
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Environmental samplingSoil, water, blood, urine, hair and radon testing in homes in Appalachia | Other | control subjects, lung cancer cases |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne M Arnold, MD principal investigator
Lucille P. Markey Cancer Center at University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Susanne Arnold at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Moderate to High Arsenic Level in Cases and Controls (time frame: up to three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.