Association of Formaldehyde Exposure to Myeloid Leukemia in Workers in Guangdong, China

NCT ID: NCT01338285

Last Updated: 2020-11-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-10
• Study Completion Date: 2020-11-06

Brief Summary

Background:

• Research suggests that occupational exposure to formaldehyde is associated with increased risk for myeloid leukemia, but the significance of these findings is uncertain because of inconsistencies among studies and lack of knowledge of how formaldehyde can cause leukemia.
• Damage to the DNA of myeloid cells (type of white blood cell) or an environmental factor not affecting the cell genetic machinery may be involved.

Objective: To determine if formaldehyde exposure is associated with genetic or other changes in myeloid cells.

Eligibility: Workers exposed to high levels of formaldehyde and unexposed workers in Guangdong Province, China.

Design:

• 40 exposed workers and 40 unexposed workers will be enrolled.
• Subjects wear small instruments at work that measure chemicals in the air for 1 or 2 days.
• Subjects have a brief physical examination and provide blood, urine, and mouth rinse samples.
• Subjects answer a questionnaire about work, smoking and drinking, use of medicines, medical history, general health, exposure to radiation and exposure to various substances at home.

Detailed Description

Research in industrial workers and professionals exposed to formaldehyde suggests that occupational exposure to this important chemical is associated with increased risk for myeloid leukemia. The significance, however, of these observations for occupational and environmental health is uncertain because of inconsistencies among epidemiologic studies and lack of a demonstrated mechanism through which formaldehyde can cause leukemia. Cytogenetic damage is one potential leukemogenic mechanism, but there are few studies of formaldehyde-exposed humans. Some experimental data suggest that epigenetic changes in myeloid cells could also be involved. We plan to study 40 workers exposed to high levels of formaldehyde and 40 unexposed controls to examine the hypothesis that formaldehyde is associated with these changes. To determine formaldehyde exposure, we will incorporate a number of methods, including questionnaires to determine potential past exposure and on-site monitoring to determine current average and peak intensities of exposure. We will then examine differences in aneuploidy and structural abnormalities in myeloid progenitor cells cultured from peripheral blood. We will specifically look for differences in genes associated with myeloid leukemia such as monosomy 7 and trisomy 8 using interphase and Octochrome FISH. We will also determine whether aberrant methylation in progenitor cells, specifically hypermethylation of genes associated with myeloid leukemia, is higher in those exposed to formaldehyde. This study will substantially contribute to our understanding of the leukemogenic potential of formaldehyde, which has important public health and regulatory implications.

Conditions

Epidemiology; Industrial Hygiene; Neoplasms

Keywords

Industry Hygiene; Molecular Epidemiology; Cancer Susceptability; Genotoxocity; FISH

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

Workers exposed to high levels of formaldehyde and unexposed workers in Guangdong Province, China.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Subjects will be recruited from a factory that manufactures plastic utensils and that has had a stable manufacturing process for the past five years.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Lan, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Guangdong National Poison Control Center (NPCC)

Guangzhou, , China

Countries

China

References

Cogliano VJ, Grosse Y, Baan RA, Straif K, Secretan MB, El Ghissassi F; Working Group for Volume 88. Meeting report: summary of IARC monographs on formaldehyde, 2-butoxyethanol, and 1-tert-butoxy-2-propanol. Environ Health Perspect. 2005 Sep;113(9):1205-8. doi: 10.1289/ehp.7542.

Reference Type: BACKGROUND

PMID: 16140628 (View on PubMed)

Hauptmann M, Lubin JH, Stewart PA, Hayes RB, Blair A. Mortality from lymphohematopoietic malignancies among workers in formaldehyde industries. J Natl Cancer Inst. 2003 Nov 5;95(21):1615-23. doi: 10.1093/jnci/djg083.

Reference Type: BACKGROUND

PMID: 14600094 (View on PubMed)

Egle JL Jr. Retention of inhaled formaldehyde, propionaldehyde, and acrolein in the dog. Arch Environ Health. 1972 Aug;25(2):119-24. doi: 10.1080/00039896.1972.10666147. No abstract available.

Reference Type: BACKGROUND

PMID: 5045063 (View on PubMed)

Other Identifiers

06-C-N178

Identifier Type: -

Identifier Source: secondary_id

999906178

Identifier Type: -

Identifier Source: org_study_id

NCT00516763

Identifier Type: -

Identifier Source: nct_alias

NCT01338181

Identifier Type: -

Identifier Source: nct_alias