- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Hong Kong, Kina
- The University of Hong Kong
-
Kunming, Kina
- Kunming Medical University
-
Shenyang, Kina
- China Medical University
-
Singapore, Kina
- National University of Singapore
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Cases
Non smoking women with lung cancer
|
Controls
Non smoking women without lung cancer
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Response-gradient for PAH exposure and lung cancer risk
Tidsramme: 2006-2034
|
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
Tidsramme: 2006-2034
|
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
Tidsramme: 2006-2034
|
Outcome will also involve the GXE analysis to explore the interaction between genetic factors and environmental exposure.
|
2006-2034
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 999906092
- 06-C-N092
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Lungeneoplasmer
-
Guangzhou First People's HospitalAfsluttet
-
Mansoura UniversityRekrutteringOne Lung VentilationEgypten
-
Chinese Chronic Respiratory Disease Research NetworkRekruttering
-
Dokuz Eylul UniversityAfsluttetOne Lung VentilationKalkun
-
Seoul National University HospitalAfsluttet
-
Seoul National University HospitalAfsluttet
-
Yonsei UniversityAfsluttetOne Lung VentilationKorea, Republikken
-
Sichuan UniversityWest China HospitalMidlertidigt ikke tilgængeligOne Lung Ventilation
-
Joseph D. TobiasAfsluttetOne-lung Ventilation (OLV)Forenede Stater
-
University Health Network, TorontoAktiv, ikke rekrutterende