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

This study has been completed.
Sponsor:
Collaborators:
China for Disease Control (CDC)
Netherlands: Ministry of Health, Welfare and Sports
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00559065
First received: November 15, 2007
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

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.


Condition
Lung Cancer
Hematopoietic Malignancy

Study Type: Observational
Official Title: A Case - Cohort Study of Hematopoietic Malignancies and Related Disorders and Lung Cancer in Benzene-Exposed Workers in China

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 3860
Study Start Date: July 2006
Detailed Description:

Benzene is a known leukemogen and may cause lymphoma as well, but its ability to , cause these conditions below 10 parts per million (ppm) in air are unclear. It is currently regulated in the United States at 1 ppm as an 8-hour time-weighted average and at a 5 ppm short-term exposure level for 15 minutes. There is a critical need to assess risks related to benzene exposure under 10 ppm because it is widely used industrially and a ubiquitous contaminant in the environment.

The National Cancer Institute (NCI) and the Chinese Academy of Preventive Medicine (CAPM), whose name was recently changed to the China Center for Disease Control (CDC) previously established a cohort of 75,000 workers exposed to benzene in 12 cities in China and 35,000 unexposed comparison workers, to investigate the relationship between benzene exposure and cancer risk, from 1972 to 1987. We followed up each worker using factory records and reported results suggesting that benzene exposure under 10 ppm may be associated with increased risk of acute non-lymphocytic cancer and could also be associated with increased risk of lymphoma and lung cancer. We have now laid the groundwork for a further epidemiologic investigation in China to evaluate health risks from lower levels of benzene exposure, particularly as present in the factories during the 1990s. The cohort was followed up through 1999, and through this effort we have identified 3260 subjects for study, including cases (HLD malignancies, n= 161; benzene poisoning, n= 1040; lung cancer, n= 560) and 1500 subjects in a cohort sub-sample to be used as the comparison group. In addition, we have identified a series of cases with benzene poisoning and controls from the same factories outside of the cohort (n = 600).

We propose to contact next-of-kin of deceased subjects (essentially all cancer cases and some members of the sub-cohort are deceased), for questionnaire-based evaluation of benzene and other exposures, and to contact living subjects (primarily the benzene poisoning cases and the sub-cohort sample) for collection of questionnaires and biologic samples. The questionnaires (formatted for direct interview of living subjects or for next-of-kin) will collect information on potential confounders needed in the analysis of benzene's effects and information on work experience outside of the study cohort factories. The biologic sample collection (13 ml blood and buccal cell rinse) will provide material primarily for study of genetic polymorphisms potentially associated with benzene metabolism and disease status. The polymorphisms being studied are relatively common in the Chinese population and may be associated with a relatively modest increase in risk (1.5 to 2-fold). Written informed consent will be obtained from all next-of-kin and all live study subjects. We will attempt to enroll 3,860 study subjects or next-of-kin. The study will be carried out with Drs. Gui-Lan Li and Song-Nian Yin and colleagues from the China CDC, Beijing, China.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559065

Locations
China
China Center for Disease Control (CDC)
Beijing, China
Sponsors and Collaborators
China for Disease Control (CDC)
Netherlands: Ministry of Health, Welfare and Sports
Investigators
Principal Investigator: Martha Linet, M.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00559065     History of Changes
Obsolete Identifiers: NCT00516568
Other Study ID Numbers: 999906205, 06-C-N205
Study First Received: November 15, 2007
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Solvents
Leukemia
Lymphoma
Occupation
Hematotoxicity
Solvent Exposure
Cancer Risk

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms
Hematologic Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on October 01, 2014