Lung Cancer Clinical Trial
Official title:
A Case - Cohort Study of Hematopoietic Malignancies and Related Disorders and Lung Cancer in Benzene-Exposed Workers in China
Verified date | November 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will examine the risks of workplace exposure to benzene, a substance known to lead to cancer of the blood and possibly of the lungs. It is used widely in industries and is a contaminant in the environment. Researchers from the National Cancer Institute and the China Center for Disease Control (formerly Chinese Academy of Preventive Medicine) had done previous studies of workers in manufacturing industries in China of people who worked at least 1 day from 1972 to 1987 in 12 cities in that country. Data were collected of approximately 75,000 workers exposed to benzene and 35,000 who were not, with the purpose of investigating the relationship between benzene exposure and cancer risk. For workers exposed to benzene, there was a significant risk of cancer affecting the blood cells and a 1.8-fold excess of lung cancer among them. This study will expand those findings and also identify the effects of benzene amounts and whether there is a genetic tendency for benzene poisoning. About 3,860 benzene-exposed workers from the 12 cities will be interviewed. Next-of-kin of deceased workers, and a subcohort (additional grouping) of participants will serve as a control group in the research. Patients who have worked at places where there was exposure to benzene will have a brief physical exam and samples of cells from a mouth rinse and samples from blood will be collected to study the genetic influence on developing blood diseases from workplace exposures. All participants or next-of-kin, for deceased, will be given a questionnaire about their work history, use of cigarettes and hair dyes, medications they take, and family history of cancer. Interviews of about 40 minutes long will be conducted at participants homes or workplaces, at a time convenient to them, and the interviews will be audiotaped.
Status | Completed |
Enrollment | 3260 |
Est. completion date | November 6, 2020 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 90 Years |
Eligibility | - INCLUSION CRITERIA: The study subjects are Chinese. Gender is not an important consideration as a risk factor in benzene-exposed workers. Subjects will be recruited by on - site collaborators in each of the 12 study cities. Participation is voluntary. Subjects may withdra from the study at any time. EXCLUSION CRITERIA: Based on the available data, no cases (an , thus no controls) will be less than 18 years of age. Any subject under 18 would be excluded from the study. Otherwise, no exclusions of potential study subjects are planned. |
Country | Name | City | State |
---|---|---|---|
China | China Center for Disease Control (CDC) | Beijing |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) | China for Disease Control (CDC) |
China,
Aksoy M, Erdem S. Followup study on the mortality and the development of leukemia in 44 pancytopenic patients with chronic exposure to benzene. Blood. 1978 Aug;52(2):285-92. — View Citation
Aksoy M. Malignancies due to occupational exposure to benzene. Am J Ind Med. 1985;7(5-6):395-402. — View Citation
Arp EW Jr, Wolf PH, Checkoway H. Lymphocytic leukemia and exposures to benzene and other solvents in the rubber industry. J Occup Med. 1983 Aug;25(8):598-602. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Benzene poisoning, Hemapoietic Malignancies and related disorders, Lung cancer | Benzene poisoning, Hemapoietic Malignancies and related disorders, Lung cancer | 1972-1999 |
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