A Population-based Case-control Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Kentucky
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susanne Arnold, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01648166
First received: April 16, 2012
Last updated: February 15, 2014
Last verified: February 2014
  Purpose

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
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Population-based Case-control Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • rate of moderate to high arsenic level in cases and controls [ Time Frame: up to three years ] [ Designated as safety issue: No ]
    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

Blood, live lymphocytes, serum, plasma, radon test kit, urine, water, soil, toenails, and hair.


Estimated Enrollment: 1800
Study Start Date: January 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648166

Contacts
Contact: Susanne M Arnold, MD 859-323-8043
Contact: Lara Sutherland 1-866-997-6372

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Lara Sutherland    866-997-6372      
Principal Investigator: Susanne M Arnold, MD         
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Susanne M Arnold, MD Lucille P. Markey Cancer Center at University of Kentucky
  More Information

No publications provided

Responsible Party: Susanne Arnold, MD, University of Kentucky
ClinicalTrials.gov Identifier: NCT01648166     History of Changes
Other Study ID Numbers: W81XWH-11-1-0781
Study First Received: April 16, 2012
Last Updated: February 15, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Kentucky:
trace
element
lung
cancer
Appalachia

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014