Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482118
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2007-06-01
Brief Title:
Smoky Coal Exposure Genetic Susceptibility and Lung Cancer in Non-Smoking Women in China
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Hospital-Based Case-Control Study of Non-Smoking Women in Xuan Wei and Fu Yua China PAH Exposure Genetic Susceptibility and Lung Cancer
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Women in Xuan Wei County China are almost all non-smokers yet they have the highest lung cancer rate in that country
Non-smoking women in Xuan Wei who use smoky coal for cooking and heating homes can inhale 10 times higher levels of polycyclic aromatic hydrocarbons PAH compounds formed in many burning organic substances including smoky coal than someone who smokes 20 cigarettes a day
Objectives
Determine the health effects of smoky coal in Xuan Wei and Fu Yuan counties in Chinas Yun Nan Province
Determine how different levels of exposure to smoky coal and other types of fuel affect the amount of smoky coal emissions that are absorbed into the body
Determine genetic risk factors for lung cancer in the study population and determine how they interact with smoky coal and PAH exposure
Eligibility
Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who have lung cancer and do or do not use smoky coal
Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who do not have lung cancer and do or do not use smoky coal
Design
-Exposure assessment study for users of smoky coal - 150 households
Use of air badges monitors and dermal badges to determine subjects exposure to smoky coal
Collection of blood urine cheek cell and sputum samples to measure the amount of smoky coal emissions absorbed into the body and evaluate the types of biologic changes they cause
Interview subjects about their health and family history occupational exposures lifestyle factors eg tobacco smoking and diet and inherited differences in genes
-Case-control study - 1000 women
Collection of blood urine cheek cell and sputum samples to measure how amount of smoky coal emissions absorbed into the body and evaluate types of biologic changes they cause
Interview subjects about their health and family history occupational exposures lifestyle factors eg tobacco smoking and diet and inherited differences in genes
Gene analysis to determine if a genetic variation is associated with an increased or decreased risk of health effects from smoky coal exposure
Women in Xuan Wei County China are almost all non-smokers yet they have the highest lung cancer rate in that country
Non-smoking women in Xuan Wei who use smoky coal for cooking and heating homes can inhale 10 times higher levels of polycyclic aromatic hydrocarbons PAH compounds formed in many burning organic substances including smoky coal than someone who smokes 20 cigarettes a day
Objectives
Determine the health effects of smoky coal in Xuan Wei and Fu Yuan counties in Chinas Yun Nan Province
Determine how different levels of exposure to smoky coal and other types of fuel affect the amount of smoky coal emissions that are absorbed into the body
Determine genetic risk factors for lung cancer in the study population and determine how they interact with smoky coal and PAH exposure
Eligibility
Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who have lung cancer and do or do not use smoky coal
Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who do not have lung cancer and do or do not use smoky coal
Design
-Exposure assessment study for users of smoky coal - 150 households
Use of air badges monitors and dermal badges to determine subjects exposure to smoky coal
Collection of blood urine cheek cell and sputum samples to measure the amount of smoky coal emissions absorbed into the body and evaluate the types of biologic changes they cause
Interview subjects about their health and family history occupational exposures lifestyle factors eg tobacco smoking and diet and inherited differences in genes
-Case-control study - 1000 women
Collection of blood urine cheek cell and sputum samples to measure how amount of smoky coal emissions absorbed into the body and evaluate types of biologic changes they cause
Interview subjects about their health and family history occupational exposures lifestyle factors eg tobacco smoking and diet and inherited differences in genes
Gene analysis to determine if a genetic variation is associated with an increased or decreased risk of health effects from smoky coal exposure
Detailed Description:
Females in Xuan Wei County are almost all non-smokers yet they have the highest lung cancer rate in China Non-smoking women in Xuan Wei who use smoky coal in their home can inhale ten times higher levels of PAHs than a 20 cigarette per day active smoker and air concentrations approach levels experienced by workers on the top-side of coke ovens Several lines of research have provided strong support that the excess lung cancer in this region is caused primarily by PAHs derived from smoky coal exposure As such this region of China provides one of the best opportunities in the world to carry out a model study of gene-environment interactions in lung cancer We have designed a hospital-based case-control study of 500 lung cancer cases and 500 controls among non-smoking women with controls to be selected through a randomized recruitment design to achieve balance for the main effects of smoky coal exposure and ultimately greater power to detect interactions The study will be carried out over a three-year period in Xuan Wei and Fu Yuan Counties in Yun Nan Province China In addition we will be carrying out an exposure assessment study n150 households to evaluate air and dermal exposure to PAHs from smoky coal use in order to model PAH exposure experienced by subjects in the case-control study We will collect buccal cell sputum blood and urine samples from all subjects The primary goal of the study is to characterize genetic risk factors at the DNA level for lung cancer in this population and determine how they interact with smoky coal and PAH exposure In addition the hospital-based design will enable us to collect venous blood samples and cryopreserve lymphocytes which will allow us to carry out state-of-the-art functional susceptibility assays such as testing ability to repair PAH-damaged DNA and apoptotic capacity and to measure integrative markers of genomic stability such as telomere length and oxidative damage in mitochondrial DNA These types of assays have never been conducted in this population and hold great promise to provide insights into cancer risk that will compliment those obtained by genotyping This study will provide an important complement to and contrast with both DCEG and extramural studies of tobacco smoking and lung cancer where unraveling the genetic component is challenging in part because hundreds of tobacco carcinogens in various combinations likely contribute
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-C-N092 | None | None | None |