- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00482118
Smoky Coal Exposure, Genetic Susceptibility, and Lung Cancer in Non-Smoking Women in China
A Hospital-Based Case-Control Study of Non-Smoking Women in Xuan Wei and Fu Yua, China: PAH Exposure, Genetic Susceptibility, and Lung Cancer
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
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Hong Kong, 중국
- The University of Hong Kong
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Kunming, 중국
- Kunming Medical University
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Shenyang, 중국
- China Medical University
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Singapore, 중국
- National University of Singapore
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Cases
Non smoking women with lung cancer
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Controls
Non smoking women without lung cancer
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Response-gradient for PAH exposure and lung cancer risk
기간: 2006-2034
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Outcome from this study will include the observation of response-gradient for PAHs exposure due to indoor burning biomass and risk of lung cancer.
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2006-2034
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Genetic polymorphisms in genes related to PAH metabolism, cell cycle control, and DNA repair associated with the risk of lung cancer
기간: 2006-2034
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Outcome will involve discovering genes related to lung cancer risks among non-smoking Asian women.
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2006-2034
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Whether polymorphisms in genes related to PAH metabolism, cell cycle control, and DNA repair modify the PAHs-lung cancer association
기간: 2006-2034
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Outcome will also involve the GXE analysis to explore the interaction between genetic factors and environmental exposure.
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2006-2034
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
폐 신생물에 대한 임상 시험
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Novartis Pharmaceuticals완전한신경내분비종양 | GI 오리진의 고급 NET | 고급 NET of Lung Origin미국, 콜롬비아, 이탈리아, 대만, 영국, 벨기에, 체코, 독일, 일본, 사우디 아라비아, 캐나다, 네덜란드, 스페인, 대한민국, 레바논, 오스트리아, 중국, 그리스, 남아프리카, 태국, 헝가리, 칠면조, 폴란드, 슬로바키아, 러시아 연방