A Case-Cohort Study of Hematopoietic Malignancies and Related Disorders and Lung Cancer in Benzene-Exposed Workers in China

NCT00559065 | Completed

• 2 other identifiers: 99990620506-C-N205
• Study Type: observational
• Target: 3,260
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Lymphoma; Acute Non-Lymphocytic Leukemia; Benzene Poisoning; Leukemia

Keywords

Case-Cohort Study; Leukemia; Lymphoma; Benzene; Blood Disorders; Solvent Exposure; Cancer Risk

Outcome Measures

Primary Outcomes (1)

• Benzene poisoning, Hemapoietic Malignancies and related disorders, Lung cancer

  Benzene poisoning, Hemapoietic Malignancies and related disorders, Lung cancer

  1972-1999

Study Arms (1)

Benzene Cohort

Benzene exposed and unexposed workers.

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• China for Disease Control (CDC): collaborator

Study Sites (1)

China Center for Disease Control (CDC)

Beijing, China

Location

Related Publications (3)

• Aksoy M. Malignancies due to occupational exposure to benzene. Am J Ind Med. 1985;7(5-6):395-402. doi: 10.1002/ajim.4700070506.

  PMID: 4003402 BACKGROUND

• 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.

  PMID: 667356 BACKGROUND

• 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.

  PMID: 6886869 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Lymphoma; Leukemia, Myeloid, Acute; Leukemia; Hematologic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Study Officials

• Nathaniel Rothman, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: July 11, 2006
• Primary Completion: December 31, 2016
• Study Completion: November 6, 2020
• Last Updated: May 12, 2021

Record last verified: 2020-11

Locations

CN (1)