Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Genetic Risk Factors for Lung Cancer in Non-Smoking Women in Xuan Wei and Fu Yuan Counties in Yun Nan Province, China
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2007
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00341926
  Purpose

RATIONALE: Gathering information about risk factors for lung cancer and exposure to smoky coal and other types of fuel in non-smoking women in China may help the study of lung cancer in the future.

PURPOSE: This clinical trial is studying genetic risk factors for lung cancer in non-smoking women in Xuan Wei and Fu Yuan Counties in Yun Nan Province, China.


Condition Intervention
Lung Cancer
Procedure: evaluation of cancer risk factors
Procedure: laboratory biomarker analysis
Procedure: molecular genetic technique
Procedure: study of high risk factors

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: A Hospital-Based Case-Control Study of Non-Smoking Women in Xuan Wei and Fu Yuan, China

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Health effects of smoky coal
  • Effect of different levels of exposure to smoky coal and other types of fuel on smoky coal emissions absorbed
  • Interaction with smoky coal and PAH exposure

Estimated Enrollment: 1150
Study Start Date: February 2006
Detailed Description:

OBJECTIVES:

  • Determine the health effects of smoky coal in non-smoking women from 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 how they interact with smoky coal and PAH exposure.

OUTLINE: Patients wear small badges designed to measure the amount of particulate matter and other chemicals they are exposed to and a small patch sampler on the wrist, neck, and shoulder to measure the amount of smoky coal exposure to the skin.

Patients undergo collection of blood and urine samples over 2 days, buccal cells on 1 day, and sputum samples over 5 days. Samples are analyzed by assays to test the 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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Newly diagnosed primary lung cancer and meets 1 of the following criteria:

      • Uses smoky coal in the home
      • Does not use smoky coal in the home
    • No lung cancer and meets 1 of the following criteria:

      • Uses smoky coal in the home
      • Does not use smoky coal in the home
  • Life-long resident of Xuan Wei or Fu Yuan, China

PATIENT CHARACTERISTICS:

  • No patients with any of the following conditions:

    • Respiratory tuberculosis
    • Respiratory infection
    • Neoplasm
    • Ischemic heart disease
    • Arterial disease
    • Respiratory disease
    • Peptic ulcer
    • Respiratory symptoms

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00341926

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
China
China National Environmental Monitoring Center Recruiting
Beijing, China, 100029
Contact: Contact Person     86-10-6711-3786        
Sponsors and Collaborators
Investigators
Principal Investigator: Qing Lan, MD National Cancer Institute (NCI)
Principal Investigator: Nathaniel Rothman, MD National Cancer Institute (NCI)
Principal Investigator: Min Shen, MD, PhD National Cancer Institute (NCI)
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000553203, NCI-06-C-N092, 999906092, CNEMC-IRB00001957
Study First Received: June 19, 2006
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00341926  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
small cell lung cancer
non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage III non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
extensive stage small cell lung cancer
limited stage small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Small Cell
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009