An observational study in Epidemiology, Industrial Hygiene and Neoplasms, sponsored by National Cancer Institute (NCI). Completed at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by National Cancer Institute (NCI) · Observational
Background:
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:
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.
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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.
Workers exposed to high levels of formaldehyde and unexposed workers in Guangdong Province, China.
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.
Time frame: 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.
Time frame: 28 years
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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