Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens

NCT01648166 | Completed Results DMC

• 1 other identifier: DOD2011-193
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

trace; element; lung; cancer; Appalachia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

lung cancer cases

subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky

Other: Environmental sampling

control subjects

subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky

Other: Environmental sampling

Interventions

Environmental sampling OTHER

Soil, water, blood, urine, hair and radon testing in homes in Appalachia

control subjects; lung cancer cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• History of any cancers other than those listed above
• Non-residents of the 5th congressional district of Kentucky
• Age 17 years or less

Sponsors & Collaborators

• Susanne Arnold: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Susanne Arnold
• Organization: University of Kentucky

smarno0@uky.edu

8592579568

Study Officials

• Susanne M Arnold, MD

  Lucille P. Markey Cancer Center at University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: July 24, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 4, 2019
• Last Updated: November 7, 2019
• Results First Posted: November 7, 2019

Record last verified: 2019-10

Locations

US (1)