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A Case - Cohort Study of Hematopoietic Malignancies and Related Disorders and Lung Cancer in Benzene-Exposed Workers in China
Sponsor study identifier
Secondary identifiers
observational
3,260
1 country
1
Study Start
July 11, 2006
Actual (reported)Primary Completion
December 31, 2016
Actual (reported)Study Completion
November 6, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 6, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 11, 2006
Actual (reported)November 15, 2007
Actual (reported)November 16, 2007
Actual (reported)December 31, 2016
Actual (reported)November 6, 2020
Actual (reported)Benzene poisoning, Hemapoietic Malignancies and related disorders, Lung cancer
Benzene poisoning, Hemapoietic Malignancies and related disorders, Lung cancer
1972-1999
Benzene exposed and unexposed workers.
From a cohort of 74,827 benzene-exposed and 35,804 unexposed workers employed (Bullet) one month in several industries and followed up during 1972-99, we identified a case-cohort population that included incident and deceased cases with hematopoietic malignancies diagnosed during those same years among exposed and unexposed workers and a 1,500 worker subcohort (1,100 exposed, 400 unexposed). The subcohort was selected by stratified random sampling (by sex, exposure status, and age at start of follow-up) from 106,641 of the cohort members. Other outcomes to be evaluated include incident cases with benzene hematotoxicity and deaths from lung cancer.
China Center for Disease Control (CDC)
Beijing, China
Aksoy M. Malignancies due to occupational exposure to benzene. Am J Ind Med. 1985;7(5-6):395-402. doi: 10.1002/ajim.4700070506.
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. No abstract available.
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.
Nathaniel Rothman, M.D.
National Cancer Institute (NCI)
3,260 participants (actual enrollment reported by the registry).
First Submitted
November 15, 2007
First Posted
November 16, 2007
Study Start
July 11, 2006
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 31, 2016
Actual (reported)Study Completion
November 6, 2020
Actual (reported)Last Updated
May 12, 2021
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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