N/A
N=520
Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01648166 ↗Enrolled (actual)
520
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Rate of Moderate to High Arsenic Level in Cases and Controls — 0.04; 0.04 mcg/dL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Environmental sampling (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Susanne Arnold
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Moderate to High Arsenic Level in Cases and Controls |
0.04; 0.04 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01648166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.