Smoky Coal Exposure, Genetic Susceptibility, and Lung Cancer in Non-Smoking Women in China

NCT00482118 | Completed

• 2 other identifiers: 99990609206-C-N092
• Study Type: observational
• Target: 3,720
• Locations: 1 country
• Sites: 4

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 China's 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 (e.g., tobacco smoking and diet), and inherited differences in genes
• Case-control study - 1,000 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 (e.g., 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

Conditions

Lung Neoplasms

Keywords

Air Pollution; Tumor Markers; Genetic Polymorphisms; Molecular Epidemiology; Environmental Epidemiology

Outcome Measures

Primary Outcomes (3)

• Response-gradient for PAH exposure and lung cancer risk

  Outcome from this study will include the observation of response-gradient for PAHs exposure due to indoor burning biomass and risk of lung cancer.

  2006-2034

• Genetic polymorphisms in genes related to PAH metabolism, cell cycle control, and DNA repair associated with the risk of lung cancer

  Outcome will involve discovering genes related to lung cancer risks among non-smoking Asian women.

  2006-2034

• Whether polymorphisms in genes related to PAH metabolism, cell cycle control, and DNA repair modify the PAHs-lung cancer association

  Outcome will also involve the GXE analysis to explore the interaction between genetic factors and environmental exposure.

  2006-2034

Study Arms (2)

Cases

Non smoking women with lung cancer

Controls

Non smoking women without lung cancer

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is the non-smoking women lived in Xuanwei and Fuyuan, Yunnan Province of China, a region with high lung cancer incidence.

* Cases: Life-long female residents of Xuan Wei and Fu Yuan Counties aged 18 to 79 years are considered the base population. Newly diagnosed primary female lung cancer cases (ICD-9 162), each diagnosis based on a minimum of clinical symptoms, chest X-ray, and a CT scan, will be identified at two hospitals in Xuan Wei County, one hospital in Fu Yuan County, and two hospitals in Qujing District. Controls: Females alive during the study period who do not have lung cancer and who are residents of Xuan Wei or Fu Yuan Counties aged 18 to 79 will be eligible for recruitment into the study. Diagnosed conditions known to be unrelated to smoky coal exposure or air pollution will be eligible for inclusion into the study. Potential controls diagnosed during the current admission with any cancer or any of the following non-cancer conditions - (respiratory tuberculosis (ICD-10: A15, 16, 19, B90), respiratory infection (A31), neoplasm (C00-D48), ischaemic heart disease (I20-I25), arterial disease (I70-I73), respiratory disease (J00-J99), peptic ulcer (K25-K27), and respiratory symptoms (R04, R06, R09), will be excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

The University of Hong Kong

Hong Kong, China

Location

Kunming Medical University

Kunming, China

Location

China Medical University

Shenyang, China

Location

National University of Singapore

Singapore, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Qing Lan, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2007
• First Posted: June 4, 2007
• Study Start: February 6, 2006
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

CN (4)