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

NCT01338285 | Completed

• 2 other identifiers: 99990617806-C-N178
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidemiology; Industrial Hygiene; Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Hematotoxicity change

  This study will determine if formaldehyde is associated with epigenetic changes in myeloid progenitor cells, including global methylation and hypermethylation in genes that have been linked to myeloid leukemia (ML) such as p15, HIC1, ER, CDH1 and ABL.

  2006-2034

• Leukemia-specific chromsome change

  This study will determine if formaldehyde exposure is associated with aneuploidy in myeloid progenitor cells using interphase-FISH, with a particular focus on monosomy of chromosome 7 and aneuploidy of other relevant chromosomes, such as trisomy 8; and if formaldehyde exposure is associated with increased levels of structural aberrations relevant for myeloid leukemogenesis \[e.g., 5q-\] in myeloid progenitor cells using OctoChrome FISH, which will evaluate aberrations in all 24chromosomes.

  28 years

Study Arms (1)

1

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We identified one factory that produced formaldehyde-melamine resins and one factory that used formaldehyde-melamine resins to manufacture plastic utensils. Monitoring of formaldehyde levels was performed in these factories during an initial screening and it was established that there were no other exposures to known or suspected leukemogens or hematotoxicants (e.g., benzene, phenol, chlorinated solvents). We selected a control population from three workplaces in the same @@@geographic region as factories with formaldehyde exposure and enrolled workers who had comparable demographic and socioeconomic characteristics and who were engaged primarily in manufacturing. Detailed inspection of the control workplaces did not identify potential for occupational exposure to formaldehyde or any other@@@hematotoxic or genotoxic chemicals in excess of exposure levels in the general population.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Guangdong National Poison Control Center (NPCC)

Guangzhou, China

Location

Related Publications (3)

• 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.

  PMID: 16140628 BACKGROUND

• 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.

  PMID: 14600094 BACKGROUND

• 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.

  PMID: 5045063 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Qing Lan, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2011
• First Posted: April 19, 2011
• Study Start: June 10, 2006
• Primary Completion: May 1, 2007
• Study Completion: November 6, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

CN (1)